Auto-injectors for administration of a medicament within a prefilled syringe

ABSTRACT

An apparatus includes a housing, a carrier, and an expandable assembly. The housing defines an opening configured to selectively place a gas chamber of the housing in fluid communication with an exterior volume. The carrier is movably disposed within the housing and is coupled to a medicament container. A proximal surface of the carrier defines a portion of a boundary of the gas chamber. The expandable assembly has a first member and a second member. The first member is coupled to an elastomeric member disposed within the medicament container, and the second member includes a valve portion. The expandable assembly transitions from a collapsed configuration to an expanded configuration when the elastomeric member moves within the medicament container. The valve portion moves relative to the opening when the expandable assembly transitions from the first to the second configuration, placing the gas chamber in fluid communication with the exterior volume.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/804,596, entitled “AUTO-INJECTORS FOR ADMINISTRATION OF A MEDICAMENTWITHIN A PREFILLED SYRINGE,” filed Feb. 28, 2020, which is acontinuation of U.S. patent application Ser. No. 15/738,008, entitled“AUTO-INJECTORS FOR ADMINISTRATION OF A MEDICAMENT WITHIN A PREFILLEDSYRINGE,” filed Dec. 19, 2017, now U.S. Pat. No. 10,576,206, which is aU.S. national stage filing under 35 U.S.C. § 371 of InternationalApplication No. PCT/US2016/40333, entitled “AUTO-INJECTORS FORADMINISTRATION OF A MEDICAMENT WITHIN A PREFILLED SYRINGE,” filed Jun.30, 2016, which claims benefit of priority to U.S. ProvisionalApplication Ser. Nos. 62/186,939, entitled “Auto-Injectors forAdministration of a Medicament Within a Prefilled Syringe,” filed Jun.30, 2015; 62/194,599, entitled “Auto-Injectors for Administration of aMedicament Within a Prefilled Syringe,” filed Jul. 20, 2015; and62/249,056, entitled “Auto-Injectors for Administration of a MedicamentWithin a Prefilled Syringe,” filed Oct. 30, 2015, each of which isincorporated herein by reference in its entirety.

BACKGROUND

The embodiments described herein relate to medicament delivery devices.More particularly, the embodiments described herein relate to medicamentdelivery devices for delivery of medicaments contained within aprefilled syringe.

Known prefilled syringes are commonly used to contain and injectmedicaments. Known prefilled syringes include a syringe body, oftenconstructed from glass, within which a medicament is contained. Thedistal end portion of some known prefilled syringes includes a stakedneedle (i.e., a needle that is permanently coupled to the syringe bodyduring manufacture), the end of which is disposed within a needle coverto maintain the sterility of the needle prior to use. Other knownprefilled syringes include a Luer fitting or adapted such that thedistal end portion of the syringe body can be coupled to a needle. Theproximal end portion of the syringe body of known prefilled syringesincludes a plunger (usually constructed from an elastomer) that definesa portion of the container closure, and that can be moved within thesyringe body to inject the medicament. The proximal end portion alsoincludes a flange to allow the user to grasp the syringe body andmanually apply a force to a piston to move the plunger, thereby causinginjection of the medicament.

Although prefilled syringes can be cost effective devices for storingand delivering medicaments, known methods for using prefilled syringesinclude manually inserting the needle into the body followed by manuallyapplying the injection force. Moreover, upon completion of theinjection, known methods include covering the needle to avoid needlesticks. Thus, known prefilled syringes are often used by healthcareprofessionals that are trained in such procedures. To facilitate theself-administration of medicaments contained in prefilled syringes, someknown autoinjectors have been adapted to contain prefilled syringes. Inthis manner, the autoinjector provides a source of stored energy forinserting the needle and/or injecting the medicament.

Known autoinjectors, however, are often designed for a medicamentcontainer having a specific size and/or shape, and are therefore oftennot configured to receive known prefilled syringes. For example, using aprefilled syringe within a known autoinjector can often result in highforces being applied to the flange of the syringe body during theinsertion operation, which can lead to breakage of the syringe flange orbody. Moreover, because many known prefilled syringes include a stakedneedle that is in fluid communication with the medicament, applying aforce to the plunger during storage and/or during an insertion operationis undesirable. For example, the application of a force against theplunger during storage, which can result, for example, when aspring-loaded member is placed in contact with the plunger, can cause inleakage of the medicament. As another example, the application of aforce against the plunger during a needle insertion event can result inthe injection of the medicament before the needle is inserted to thedesired location. Similarly stated, some known auto-injectors are notconfigured to control the force applied to the plunger within thesyringe body during storage and/or needle insertion.

Known autoinjectors configured to incorporate a prefilled syringe ofteninclude a spring-based actuation system that moves a piston rod toinsert the needle and inject the medicament. The size (e.g., length) ofsuch known systems, however, can be larger than desired because of theneed to incorporate the piston rod.

Moreover, known medicaments or therapeutic substances are formulated toinclude high molecular weight compounds, compounds with complexmolecular structures, living cells, and/or biologics. Such medicamentsoften have a very high viscosity (e.g., greater than about 100centipoise at room temperature), which must be accommodated by thedelivery system. Accordingly, many know auto-injectors that accommodatea prefilled syringe may not be able to provide sufficient force and/ordevelop the desired flow rate for effective delivery.

Thus, a need exists for improved methods and devices for deliveringmedicaments contained within a prefilled syringe.

SUMMARY

Medicament delivery devices for administration of medicaments containedwithin a prefilled syringe are described herein. In some embodiments, anapparatus includes a housing, a carrier, and an expandable assembly. Aside wall of the housing defines an opening configured to selectivelyplace a gas chamber defined by the housing in fluid communication withan exterior volume. The carrier is configured to be movably disposedwithin the housing and coupled to a medicament container. A proximalsurface of the carrier defines a portion of a boundary of the gaschamber. The expandable assembly has a first member and a second member.The first member is coupled to an elastomeric member disposed within themedicament container, and the second member includes a valve portion.The expandable assembly is configured to transition from a collapsedconfiguration to an expanded configuration when the elastomeric membermoves within the medicament container. The valve portion moves relativeto the opening when the expandable assembly transitions from the firstconfiguration to the second configuration to place the gas chamber influid communication with the exterior volume.

In some embodiments, an apparatus includes a housing, an energy storagemember, a medicament container, and a carrier. The housing has a housinglength along a longitudinal axis. The energy storage member is disposedwithin the housing, and is configured to produce a force when theactuated. The medicament container is disposed within the housing, andhas a container length. The medicament container has an elastomericmember disposed therein, and is coupled to a needle. The carrier iscoupled to the medicament container. The carrier is configured to movefrom a first carrier position to a second carrier position in responseto the force produced by the energy storage member such that the needlemoves from a first needle position, in which the needle is disposedwithin the housing, to a second needle position, in which a portion ofthe needle extends from the housing. The elastomeric member isconfigured to move within the medicament container from a first positionto a second position to convey a medicament from the medicamentcontainer when the carrier is in the second carrier position. A ratio ofthe housing length to the container length is less than about 1.5. Insome embodiments, the medicament container and needle are furtherconfigured to be moved from the second position to a third positionwhereby the needle is retracted up within the housing.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-3 are schematic illustrations of a medicament delivery deviceaccording to an embodiment, in a first configuration, a secondconfiguration, and a third configuration, respectively.

FIGS. 4-6 are schematic illustrations of a medicament delivery deviceaccording to an embodiment, in a first configuration, a secondconfiguration, and a third configuration, respectively.

FIGS. 7 and 8 are schematic illustrations of a medicament deliverydevice according to an embodiment, in a first configuration and a secondconfiguration, respectively.

FIGS. 9 and 10 are perspective front and rear views, respectively, of amedical injector according to an embodiment, in a first configuration.

FIG. 11 is a perspective rear view of the medical injector illustratedin FIGS. 9 and 10 , with the safety lock removed.

FIG. 12 is a perspective view of a housing of the medical injectorillustrated in FIGS. 9 and 10 .

FIG. 13 is a cross-sectional view of the housing illustrated in FIG. 12.

FIGS. 14 and 15 are a perspective view and a cross-sectional view,respectively, of a proximal cap of the medical injector illustrated inFIG. 9 .

FIGS. 16 and 17 are front views of a medicament delivery mechanism ofthe medical injector shown in FIGS. 9 and 10 .

FIG. 18 is a front view of the medical injector shown in FIGS. 9 and 10, in the first configuration.

FIG. 19 is a front cross-sectional view of the medical injector shown inFIGS. 9 and 10 , in the first configuration.

FIG. 20 is an enlarged cross-sectional view of a portion of the medicalinjector shown in FIGS. 9 and 10 , in the first configuration.

FIG. 21 is an enlarged cross-sectional view of a portion of the medicalinjector shown in FIGS. 9 and 10 , in the first configuration.

FIGS. 22 and 23 are a perspective view and a cross-sectional view,respectively, of a carrier assembly of the medical injector shown inFIGS. 9 and 10 .

FIG. 24 is a perspective view of the carrier assembly of the medicalinjector shown in FIGS. 9 and 10 .

FIG. 25 is a cross-sectional view of the carrier assembly and amedicament container of the medical injector shown in FIGS. 9 and 10 .

FIG. 26 is an exploded view of a medicament container assembly of themedical injector shown in FIGS. 9 and 10 .

FIG. 27 is a perspective view of a gas vent assembly of the medicalinjector shown in FIGS. 9 and 10 .

FIGS. 28 and 29 are exploded views of the gas vent assembly of themedical injector shown in FIGS. 9 and 10 .

FIGS. 30 and 31 are perspective views of a safety lock of the medicalinjector shown in FIGS. 9 and 10 .

FIGS. 32 and 33 are perspective views of a system actuator of themedical injector shown in FIGS. 9 and 10 .

FIG. 34 is a front cross-sectional view of the medical injector shown inFIGS. 9 and 10 , in a second configuration (safety lock removed).

FIG. 35 is a front cross-sectional view of the medical injector shown inFIGS. 9 and 10 , in a third configuration (actuated).

FIG. 36 is a front view of the medical injector shown in FIGS. 9 and 10, in a fourth configuration (needle inserted).

FIG. 37 is a front cross-sectional view of the medical injector shown inFIGS. 9 and 10 , in the fourth configuration (needle inserted).

FIG. 38 is an enlarged cross-sectional view of the medical injectorshown in FIGS. 9 and 10 , in the fourth configuration.

FIG. 39 is a front view of the medical injector shown in FIGS. 9 and 10, in a fifth configuration (medicament delivered).

FIG. 40 is a front cross-sectional view of the medical injector shown inFIGS. 9 and 10 , in the fifth configuration (medicament delivered).

FIG. 41 is a perspective cross-sectional view of the medical injectorshown in FIGS. 9 and 10 , in the fifth configuration (medicamentdelivered).

FIG. 42 is a front view of the medical injector shown in FIGS. 9 and 10, in a sixth configuration (needle retracted).

FIG. 43 is a front cross-sectional view of the medical injector shown inFIGS. 9 and 10 , in a sixth configuration (needle retracted).

FIG. 44 is a photograph of a medicament delivery device (or modelthereof) according to an embodiment.

FIGS. 45-48 are various views of a medicament delivery device (or modelsthereof) according to an embodiment.

FIGS. 49 and 50 are perspective views of a cover of a medical injector,according to an embodiment.

FIGS. 51-54 are schematic illustrations of a medicament delivery deviceaccording to an embodiment, in a first, second, third and fourthconfiguration, respectively.

FIGS. 55-58 are schematic illustrations of a medicament delivery deviceaccording to an embodiment, in a first, second, third and fourthconfiguration, respectively.

FIGS. 59 and 60 are perspective front and rear views, respectively, of amedical injector according to an embodiment, in a first configuration.

FIG. 61 is a perspective rear view of the medical injector illustratedin FIGS. 59 and 60 , with the safety lock removed.

FIG. 62 is a perspective view of a housing of the medical injectorillustrated in FIGS. 59 and 60 .

FIG. 63 is a cross-sectional view of the housing illustrated in FIG. 62.

FIG. 64 is a perspective view of a proximal cap of the medical injectorillustrated in FIG. 59 .

FIG. 65 is a front view of a medicament delivery mechanism of themedical injector shown in FIGS. 59 and 60 .

FIG. 66 is a front view of the medical injector shown in FIGS. 59 and 60, in the first configuration.

FIG. 67 is a front cross-sectional view of the medical injector shown inFIGS. 59 and 60 , in the first configuration.

FIG. 68 is an enlarged cross-sectional view of a portion of the medicalinjector shown in FIGS. 59 and 60 , in the first configuration.

FIG. 69 is an exploded views of the gas vent assembly of the medicalinjector shown in FIGS. 59 and 60 .

FIGS. 70 and 71 are perspective views of a safety lock of the medicalinjector shown in FIGS. 59 and 60 .

FIG. 72 is a perspective view of a system actuator of the medicalinjector shown in FIGS. 59 and 60 .

FIG. 73 is a front cross-sectional view of the medical injector shown inFIGS. 59 and 60 , in a second configuration (safety lock removed).

FIG. 74 is a front cross-sectional view of the medical injector shown inFIGS. 59 and 60 , in a third configuration (actuated).

FIG. 75 is a front cross-sectional view of the medical injector shown inFIGS. 59 and 60 , in the fourth configuration (needle inserted).

FIG. 76 is a front cross-sectional view of the medical injector shown inFIGS. 59 and 60 , in the fifth configuration (medicament delivered).

FIG. 77 is a perspective cross-sectional view of the medical injectorshown in FIGS. 59 and 60 , in the fifth configuration (medicamentdelivered).

FIG. 78 is a front cross-sectional view of the medical injector shown inFIGS. 59 and 60 , in a sixth configuration (needle retracted).

FIGS. 79 and 80 are a front view and a perspective view, respectively ofa medical injector according to an embodiment.

FIGS. 81 and 82 are a front view and a rear view, respectively of amedical injector including an electronic circuit system, according to anembodiment.

FIGS. 83 and 84 are front perspectives view of the medical injectorincluding the electronic circuit system shown in FIGS. 81 and 82 .

FIG. 85 is a rear perspective view of the medical injector including theelectronic circuit system shown in FIGS. 81 and 82 .

FIGS. 86 and 87 are a front view and a rear view, respectively of amedical injector including an electronic circuit system, according to anembodiment.

FIGS. 88 and 89 are front perspective views of the medical injectorincluding the electronic circuit system shown in FIGS. 86 and 87 .

FIG. 90 is a flow chart of a method of delivering a medicament accordingto an embodiment.

FIGS. 91-94 are schematic illustrations of a medicament delivery deviceaccording to an embodiment, in a first, second, third and fourthconfiguration, respectively.

DETAILED DESCRIPTION

Medicament delivery devices for administration of medicaments containedwithin a prefilled syringe are described herein. In some embodiments, anapparatus includes an apparatus includes a housing, a carrier, and anexpandable assembly. A side wall of the housing defines an openingconfigured to selectively place a gas chamber defined by the housing influid communication with an exterior volume. The carrier is configuredto be movably disposed within the housing and coupled to a medicamentcontainer. A proximal surface of the carrier defines a portion of aboundary of the gas chamber. The expandable assembly has a first memberand a second member. The first member is coupled to an elastomericmember disposed within the medicament container, and the second memberincludes a valve portion. The expandable assembly is configured totransition from a collapsed configuration to an expanded configurationwhen the elastomeric member moves within the medicament container. Thevalve portion moves relative to the opening when the expandable assemblytransitions from the first configuration to the second configuration toplace the gas chamber in fluid communication with the exterior volume.

In some embodiments, an apparatus includes a housing, an energy storagemember, a medicament container, and a carrier. The housing has a housinglength along a longitudinal axis. The energy storage member is disposedwithin the housing, and is configured to produce a force when theactuated. The medicament container is disposed within the housing, andhas a container length. The medicament container has an elastomericmember disposed therein, and is coupled to a needle. The carrier iscoupled to the medicament container. The carrier is configured to movefrom a first carrier position to a second carrier position in responseto the force produced by the energy storage member such that the needlemoves from a first needle position, in which the needle is disposedwithin the housing, to a second needle position, in which a portion ofthe needle extends from the housing. The elastomeric member isconfigured to move within the medicament container from a first positionto a second position to convey a medicament from the medicamentcontainer when the carrier is in the second carrier position. A ratio ofthe housing length to the container length is less than about 1.5.

In some embodiments, an apparatus includes a housing, a medicamentcontainer, and a gas vent assembly. The housing defines a gas chamber,and has a side wall that defines an opening that selectively places thegas chamber in fluid communication with an exterior volume. Themedicament container has an elastomeric member disposed therein. Theelastomeric member is configured to move within the medicament containerfrom a first position to a second position to convey a medicament fromthe medicament container in response to a pressurized gas being conveyedinto the gas chamber. A proximal surface of the elastomeric memberdefines a portion of a boundary of the gas chamber. The gas ventassembly has a first member and a second member. The first member iscoupled to the elastomeric member, and the second member coupled withinthe opening. The first member of the gas vent assembly is configured tomove with the elastomeric member such that the second member movesrelative to the opening to fluidically couple the gas chamber with theexterior volume when the elastomeric member is in the second position.

In some embodiments, an apparatus includes a housing defining a gaschamber, a medicament container assembly disposed within the housing, aretraction spring, an expandable assembly, and an energy storage member.The medicament container assembly includes a needle fluidically coupledto the medicament container. The medicament container assembly isconfigured to move between a first needle position, in which the needleis disposed within the housing, and a second needle position in which aportion of the needle extends from the housing. The retraction spring isconfigured to bias the medicament container assembly towards the firstneedle position. The expandable assembly is configured to transitionbetween a collapsed configuration and an expanded configuration. Theexpandable assembly includes a proximal member and a distal member. Theenergy storage member is configured to produce a pressurized gas withinthe gas chamber. The pressurized gas exerts a force to move themedicament container assembly from the first needle position to thesecond needle position and to move an elastomeric member within themedicament container to convey a medicament from the medicamentcontainer via the needle. The proximal member of the expandable assemblyis configured to actuate a valve to release the pressurized gas from thegas chamber when the expandable assembly is transitioned from thecollapsed configuration to the expanded configuration.

In some embodiments, an apparatus includes a housing (that defines a gaschamber), an energy storage member, a first medicament containerassembly, and a second medicament container assembly. The energy storagemember is disposed within the housing, and is configured to produce apressurized gas within the gas chamber. Each of the first medicamentcontainer assembly and the second medicament container assembly isdisposed within the housing. The first medicament container assemblyincludes a first container body and a first elastomeric member disposedwithin the first container body. The first medicament container assemblyincludes a first needle coupled to a distal end portion of the firstcontainer body. The first medicament container assembly is configured tomove within the housing in response to a force exerted by thepressurized gas such that the first needle moves from within the housingto an exterior volume outside of the housing. The first elastomericmember is configured to move within the first container body to convey afirst medicament contained therein in response to the force. The secondmedicament container assembly includes a second container body and asecond elastomeric member disposed within the second container body. Thesecond medicament container assembly includes a second needle coupled toa distal end portion of the second container body. The second medicamentcontainer assembly is configured to move within the housing in responseto the force such that the second needle moves from within the housingto the exterior volume. The second elastomeric member is configured tomove within the second container body to convey a second medicamentcontained therein in response to the force.

In some embodiments, an apparatus includes a housing (that defines a gaschamber), an energy storage member, a first medicament containerassembly, and a second medicament container assembly. The energy storagemember is disposed within the housing, and is configured to produce apressurized gas within the gas chamber. Each of the first medicamentcontainer assembly and the second medicament container assembly isdisposed within the housing. The first medicament container assemblyincludes a first carrier and a first container body. The first carrieris coupled to the first container body, and is configured to move withinthe housing to convey a first medicament in response to a force exertedby the pressurized gas. A proximal surface of the first carrier definesa first portion of a boundary of the gas chamber. The second medicamentcontainer assembly includes a second carrier and a second containerbody. The second carrier is coupled to the second container body and isconfigured to move within the housing to convey a second medicament inresponse to the force exerted by the pressurized gas. A proximal surfaceof the second carrier defines a second portion of the boundary of thegas chamber.

In some embodiments, an apparatus includes a housing, a first medicamentcontainer, a second medicament container, and a movable member. Thefirst medicament container and the second medicament container areconfigured to move within the housing between a first position and asecond position in response to a force produced by an energy storagemember. The first medicament container includes a first plunger disposedtherein and a first needle. The second medicament container includes asecond plunger disposed therein and a second needle. The movable memberis configured to move within the housing in response to the force toinsert the first needle and the second needle into a target tissue inthe same operation. A portion of the movable member is configured todeform when the first needle and the second needle are inserted suchthat at least a portion of the force is exerted upon the first plungerand the second plunger. In response to the portion of the force, thefirst plunger is configured to move within the first medicamentcontainer to convey a first medicament from the first medicamentcontainer via the first needle, and the second plunger is configured tomove within the second medicament container to convey a secondmedicament from the second medicament container via the second needle.

In some embodiments, an apparatus includes a housing (that defines a gaschamber), an energy storage member, a medicament container assembly, anda carrier. The energy storage member is disposed within the housing, andis configured to produce a pressurized gas within the gas chamber. Themedicament container assembly is disposed within the housing, andincludes a container body and an elastomeric member disposed within thecontainer body. The medicament container assembly includes a needlecoupled to a distal end portion of the container body. The carrier iscoupled to the medicament container assembly. A proximal surface of thecarrier defines a portion of a boundary of the gas chamber. The carrieris configured to move within the housing from a first carrier positionto a second carrier position in response to a force exerted by thepressurized gas on the proximal surface of the carrier. The carrierincludes a first seal member and a second seal member. The first sealmember is in sliding contact with an inner surface of the housing tofluidically isolate the gas chamber. The second seal member is incontact with a proximal end portion of the container body to fluidicallyisolate the gas chamber. The first seal member in a fixed positionrelative to the second seal member.

In some embodiments, a method includes placing a housing of a medicalinjector into contact with a target location. The housing defines a gaschamber, and encloses an energy storage member, a first medicamentcontainer assembly, and a second medicament container assembly. Thefirst medicament container assembly includes a first container body, afirst elastomeric member disposed within the first container body, and afirst needle coupled to a distal end portion of the first containerbody. The first needle is disposed within the housing. The secondmedicament container assembly includes a second container body, a secondelastomeric member disposed within the second container body, and asecond needle coupled to a distal end portion of the second containerbody. The second needle is disposed within the housing. The methodincludes actuating the energy storage member to produce a pressurizedgas within the gas chamber of the housing. The first medicamentcontainer assembly moves within the housing in response to a forceexerted by the pressurized gas such that the first needle moves fromwithin the housing to an exterior volume outside of the housing. Thefirst elastomeric member moves within the first container body to conveya first medicament contained therein in response to the force. Thesecond medicament container assembly moves within the housing inresponse to the force exerted by the pressurized gas such that thesecond needle moves from within the housing to the exterior volume. Thesecond elastomeric member moves within the second container body toconvey a second medicament contained therein in response to the force.

As used herein, the term “medicament” includes any constituent of atherapeutic substance. A medicament can include such constituentsregardless of their state of matter (e.g., solid, liquid or gas).Moreover, a medicament can include the multiple constituents that can beincluded in a therapeutic substance in a mixed state, in an unmixedstate and/or in a partially mixed state. A medicament can include boththe active constituents and inert constituents of a therapeuticsubstance. Accordingly, as used herein, a medicament can includenon-active constituents such as, water, colorant or the like.

The term “about” when used in connection with a referenced numericindication means the referenced numeric indication plus or minus up to10 percent of that referenced numeric indication. For example, “about100” means from 90 to 110.

In a similar manner, term “substantially” when used in connection with,for example, a geometric relationship, a numerical value, and/or a rangeis intended to convey that the geometric relationship (or the structuresdescribed thereby), the number, and/or the range so defined is nominallythe recited geometric relationship, number, and/or range. For example,two structures described herein as being “substantially parallel” isintended to convey that, although a parallel geometric relationship isdesirable, some non-parallelism can occur in a “substantially parallel”arrangement. By way of another example, a structure defining a volumethat is “substantially 0.50 milliliters (mL)” is intended to conveythat, while the recited volume is desirable, some tolerances can occurwhen the volume is “substantially” the recited volume (e.g., 0.50 mL).Such tolerances can result from manufacturing tolerances, measurementtolerances, and/or other practical considerations (such as, for example,minute imperfections, age of a structure so defined, a pressure or aforce exerted within a system, and/or the like). As described above, asuitable tolerance can be, for example, of ±10% of the stated geometricconstruction, numerical value, and/or range. Furthermore, although anumerical value modified by the term “substantially” can allow forand/or otherwise encompass a tolerance of the stated numerical value, itis not intended to exclude the exact numerical value stated.

As used herein, the term “set” can refer to multiple features or asingular feature with multiple parts. For example, when referring to setof walls, the set of walls can be considered as one wall with multipleportions, or the set of walls can be considered as multiple, distinctwalls. Thus, a monolithically-constructed item can include a set ofwalls. Such a set of walls can include, for example, multiple portionsthat are either continuous or discontinuous from each other. A set ofwalls can also be fabricated from multiple items that are producedseparately and are later joined together (e.g., via a weld, an adhesive,or any suitable method).

As used in this specification and the appended claims, the words“proximal” and “distal” refer to direction closer to and away from,respectively, an operator of the medical device. Thus, for example, theend of the medicament delivery device contacting the patient's bodywould be the distal end of the medicament delivery device, while the endopposite the distal end would be the proximal end of the medicamentdelivery device.

The term “fluid-tight” is understood to encompass hermetic sealing(i.e., a seal that is gas-impervious) as well as a seal that is onlyliquid-impervious. The term “substantially” when used in connection with“fluid-tight,” “gas-impervious,” and/or “liquid-impervious” is intendedto convey that, while total fluid imperviousness is desirable, someminimal leakage due to manufacturing tolerances, or other practicalconsiderations (such as, for example, the pressure applied to the sealand/or within the fluid), can occur even in a “substantiallyfluid-tight” seal. Thus, a “substantially fluid-tight” seal includes aseal that prevents the passage of a fluid (including gases, liquidsand/or slurries) therethrough when the seal is maintained at pressuresof less than about 5 psig, less than about 10 psig, less than about 20psig, less than about 30 psig, less than about 50 psig, less than about75 psig, less than about 100 psig, and all values in between. Anyresidual fluid layer that may be present on a portion of a wall of acontainer after component defining a “substantially-fluid tight” sealare moved past the portion of the wall are not considered as leakage.

FIGS. 1-3 are schematic illustrations of a medicament delivery device1000 according to an embodiment. The medicament delivery device 1000includes a housing 1100, a carrier 1360 disposed within the housing1100, a medicament container assembly 1200, and an expandable assembly1320. The housing 1100 defines a gas chamber 1139 that receives apressurized gas from a suitable energy storage member (not shown). Thegas chamber 1139 can be of any suitable size and shape, and can be, forexample, a portion of the volume defined by the housing 1100 withinwhich a portion of the medicament container assembly 1200 and/or thecarrier 1360 is disposed. The housing includes a side wall 1110 thatdefines an opening 1112 (see FIG. 3 ) that can selectively place the gaschamber 1139 in fluid communication with an exterior volume. Asdescribed in more detail below, the opening 1112 and the valve portion1145 of the expandable assembly allow the gas pressure within the gaschamber 1139 to be reduced upon completion of the injection event.

The housing 1100 can be any suitable size, shape, or configuration andcan be made of any suitable material. For example, in some embodiments,the housing 1100 is an assembly of multiple parts formed from a plasticmaterial and defines a substantially rectangular shape when assembled.In other embodiments, the housing 1100 can have a substantiallycylindrical shape.

The medicament container assembly 1200 has a container body 1210 thatdefines a volume that contains (i.e., is filled with or partially filledwith) a medicament. The distal end portion of the medicament containerbody 1210 includes a neck or opening through which the medicament can bedelivered. In some embodiments, the medicament container assembly 1200can include a delivery member coupled to the container body 1210, andthrough which the medicament is delivered. For example, in someembodiments, the medicament container assembly 1200 includes a needle, anozzle, a mouthpiece, or the like. In some embodiments, the medicamentcontainer assembly 1200 can be a prefilled syringe having a needlestaked thereto, of the types shown and described herein.

The medicament container assembly 1200 includes an elastomeric member1217 (i.e., a plunger) that seals the medicament within the containerbody 1210. The elastomeric member 1217 is configured to move within thecontainer body to inject the medicament from the medicament containerassembly 1200. The elastomeric member 1217 can be of any design orformulation suitable for contact with the medicament. For example, theelastomeric member 1217 can be formulated to minimize any reduction inthe efficacy of the medicament that may result from contact (eitherdirect or indirect) between the elastomeric member 1217 and themedicament. For example, in some embodiments, the elastomeric member1217 can be formulated to minimize any leaching or out-gassing ofcompositions that may have an undesired effect on the medicament. Inother embodiments, the elastomeric member 1217 can be formulated tomaintain its chemical stability, flexibility and/or sealing propertieswhen in contact (either direct or indirect) with the medicament over along period of time (e.g., for up to six months, one year, two years,five years or longer).

The carrier 1360 is disposed within the housing, and is configured to becoupled to a medicament container assembly 1200. The carrier 1360 can becoupled to the medicament container assembly 1200 in any suitablemanner. For example, as shown, in some embodiments, the carrier 1360 candefine an opening within which a portion of the container body 1210 canbe received. The carrier 1360 can define, for example, a shoulder,protrusion, or other structure that couples to a portion of thecontainer body 1210 (e.g., a flange, a side wall or the like). In otherembodiments, the carrier 1360 can surround only a portion of thecontainer body 1210. In yet other embodiments, the carrier 1360 can beconstructed from multiple components that are joined together (e.g., viaa hinged joint, a mechanical fastener or the like) to surround and/or becoupled to the medicament container assembly 1200.

The carrier 1360 includes a proximal surface 1376 that defines a portionof a boundary of the gas chamber 1139. In this manner, when apressurized gas is conveyed into the gas chamber 1139, the pressuretherein will produce a force on the proximal surface 1376 and/or theelastomeric member 1217. As described below, by selectively venting thegas chamber 1139 via the opening 1112, movement of the carrier 1360within the housing 1100 and/or the elastomeric member 1217 within thecontainer body 1210 can be controlled. In some embodiments, the carrier1360 includes a seal portion or a seal member that produces afluid-tight seal between the carrier 1360 and the housing 1100.Accordingly, when pressurized gas flows into gas chamber 1139, thevolume between the proximal surface 1376 of the carrier 1360 and theproximal end portion of the housing 1100 is sealed (i.e., is fluidicallyisolated from the exterior volume).

In some embodiments, the carrier 1360 is configured to move within thehousing 1100 from a first carrier position to a second carrier positionin response to a pressurized gas being conveyed into the gas chamber1139. In such embodiments, movement of the carrier 1360 can producemovement of the medicament container assembly 1200 to facilitatedelivery of the medicament therein.

The expandable assembly 1310 includes a first member 1320 and a secondmember 1340. The first member 1320 is coupled to the elastomeric member1217. In this manner, movement of the elastomeric member 1217 within thecontainer body 1210 (i.e., to expel the medicament therefrom) producesmovement of at least a portion of the first member 1320. Similarlystated, when the elastomeric member 1217 is exposed to a force (e.g.,produced by the pressurized gas within the gas chamber 1139 actingdirectly on a proximal surface of the elastomeric member 1217), movementof the elastomeric member 1217 exerts a force on the first member 1320of the expandable assembly 1310. Specifically, distal movement of theelastomeric member 1217 can produce a tensile force on the first member1320.

The first member 1320 can be coupled to the elastomeric member 1217 inany suitable manner. For example, in some embodiments, the first member1320 can be threadedly coupled to the elastomeric member 1217. In otherembodiments, the first member 1320 can be press fit into a bore of orabout a protrusion of the elastomeric member 1217. In yet otherembodiments, the first member 1320 can be bonded to the elastomericmember 1217 via an adhesive, a weld process, or the like.

The second member 1340 includes a valve portion 1345. In someembodiments, the valve portion 1345 can be coupled within and/or inproximity to the opening 1112. Thus, as described below, when theexpandable assembly 1310 transitions from a first (or collapsed)configuration to a second (or expanded) configuration, the valve portion1345 can move relative to the opening 1112 to place the gas chamber 1139in fluid communication with the exterior volume. Specifically, prior touse the medicament delivery device 1000 is in a first configuration, asshown in FIG. 1 . When the medicament delivery device 1000 is in itsfirst configuration, the elastomeric member 1217 is disposed proximallywithin the container body 1210, and the medicament container assembly1200 contains a dose of medicament. Further, the expandable assembly1310 is in its first (or collapsed) configuration. When in its collapsedconfiguration the expandable assembly 1310 has a first size, asindicated by the length L₁ of the first member 1320.

When the medicament delivery device 1000 is actuated, a pressurized gasflows into the gas chamber 1139, as shown by the arrow AA in FIG. 2 .The pressure within the gas chamber 1139 exerts a force on the proximalsurface of the carrier 1360 and on the elastomeric member 1217. Theforce causes the elastomeric member 1217 to move distally within thecontainer body 1210, as shown by the arrow BB, thereby expelling themedicament therefrom. As the elastomeric member 1217 moves, theattachment between the first member 1320 and the elastomeric member 1217begins to expand the expandable assembly 1310. As shown, as theexpandable assembly 1310 transitions from its first configuration, ithas a second size, as indicated by the length L₂ of the first member1320. The second size is larger than the first size.

The continued movement of the elastomeric member 1217, as shown by thearrow DD in FIG. 3 , causes the expandable assembly 1310 to transitionfrom its first (or collapsed) configuration to its second (or expanded)configuration. As shown, when the expandable assembly 1310 is in itssecond configuration, it has a third size, as indicated by the length L₃of the first member 1320. The third size is larger than the second size.During this transition, the valve portion 1345 of the second member 1340moves relative to the opening 1112, thereby placing the gas chamber 1139in fluid communication with the exterior volume. In this manner, thepressurized gas (and thus the pressure) within the gas chamber 1139 canbe released, as shown by the arrow CC, as a function of the position ofthe elastomeric member 1217 within the container body 1210. In thismanner, further movement of the elastomeric member 1217 within thecontainer body 1210 (produced by the pressurized gas) can be stoppedwhen a desired dose volume has been expelled.

Each of the first member 1320 or the second member 1340 can beconstructed from any suitable material to accommodate the desiredexpansion of the expandable member 1310. For example, in someembodiments, each of the first member 1320 or the second member 1340 canbe constructed from a resilient material (i.e., a material thatelastically deforms and stores energy therein when exposed to a force).For example, in some embodiments, each of the first member 1320 or thesecond member 1340 can be a spring. In other embodiments, each of thefirst member 1320 or the second member 1340 can be constructed fromrigid (i.e., substantially non-deformable) material. In suchembodiments, the expansion of the expandable assembly 1310 can beachieved by relative movement between the first member 1320 and thesecond member 1340. In some embodiments, for example, the first member1320 and the second member 1340 can be in a nested configuration.

Although the medicament delivery device 1000 is shown as including thecarrier 1360 to facilitate coupling the medicament container assembly1200 within the housing 1100, in other embodiments, a medicamentdelivery device can be devoid of a carrier. For example, in someembodiments, the medicament container assembly 1200 (e.g., a prefilledsyringe) can be sealingly coupled within the housing 1100 without acarrier.

In some embodiments, a gas-powered medicament delivery device canproduce a compact device, in which the outer dimensions of the housingis not substantially larger than the length of the medicament containerdisposed therein. For example, as shown and described herein, in someembodiments, a medicament delivery device can be devoid of a mechanicallinkage that exerts or transfers a force to an elastomeric member toexpel a medicament from a medicament container therein. Similarlystated, in some embodiments, a medicament delivery device can be devoidof mechanical linkages (rams, rods) that transfer force to theelastomeric member. Rather, as shown above with respect to the device1000, in some embodiments, the elastomeric member can exert a force ontoa member (e.g., an expandable member) to provide control over thedelivery. Such medicament delivery devices (or medicament deliverymechanisms) are considered to be “pistonless” systems. As one example,in a pistonless, gas-powered auto-injector, the force exerted by the gascan move the medicament container relative to the housing and similarly,can move the elastomeric member relative to (e.g., within) themedicament container. In some embodiments, by not including a movablemechanism, a piston, and/or the like, a height of the medical injector1000 can be reduced relative to, for example, the height of a devicethat includes a rigid, single length piston.

For example, any of the medicament delivery devices described herein caninclude any suitable “pistonless” design, such as those described inInternational Patent Application No. PCT/US16/23995, entitled “DEVICESAND METHODS FOR DELIVERING A LYOPHILIZED MEDICAMENT,” filed on Mar. 24,2016, which is incorporated herein by reference in its entirety.

In some embodiments, the characteristics of the medicament, themedicament container and the needle are such that the force required toachieve the desired injection is not possible via manual injection.Accordingly, in some embodiments a device can include an energy storagemember configured to produce the desired force (and/or pressure withinthe medicament container) to deliver the medicament. For example, incertain circumstances, the pressure of the medicament within aneedle-based medicament container can be modeled by the Hagen-Poiseuillelaw, as indicated below:

P=(8*μ*L*Q)/(Π*R ⁴)   (1)

where P is the pressure of the medicament within the medicamentcontainer, μ is the viscosity of the medicament, L is the length of theneedle (not shown), Q is the flow rate of the medicament through theneedle, and R is the radius of the lumen defined by the needle. Becausethe pressure (and/or force) required to inject a high viscosity fluidthrough a small-bore needle is proportional to the inverse of the radiusof the lumen of the needle to the fourth power, the pressure of themedicament within the medicament container necessary to achieve thedesired flow rate can, at times, be relatively high. By including agas-based energy storage member, the desired pressure can be achieved.

In some embodiments, the energy storage member can be configurable toinclude various amounts of stored energy without changing the size ofthe energy storage member. In such embodiments, therefore, a high force(e.g., to inject viscous medicaments) can be achieved in the samepackaging that is used for lower viscosity medicaments. For example, insome embodiments, the energy storage member can be a compressed gascylinder having any desired pressure (and thus, mass) of gas therein.Accordingly, the pressure and/or force can be achieved to complete theoperations described herein, regardless of the medicament.

In such embodiments, the use of a non-mechanical energy storage member(e.g., gas, propellant, magnetic, electronic or the like) can produce asufficiently high force to produce the desired pressure within themedicament container to produce the desired injection. For example, insuch embodiments having a larger diameter, the amount of force needed toproduce a desired internal pressure increases significantly. In someembodiments, any of the medicament delivery devices shown herein caninclude a gas-based energy storage system configured to produce a gaspressure (e.g., within the gas chamber) of between about 200 psi andabout 2700 psi. In some embodiments, any of the injectors shown hereincan include a gas-based energy storage system configured to produce agas pressure of about 200 psi, 300 psi, 400 psi, 500 psi, 600 psi, 700psi, 800 psi, 900 psi, 1100 psi, 1200 psi, 1300 psi, 1500 psi, 1700 psi,1900 psi, 2100 psi, 2300 psi, 2500 psi, or 2700 psi. The gas pressurecan be produced by any suitable mechanism, such as, for example, bypuncturing a compressed gas container, releasing a propellant (e.g.,hydrofluoroalkane), releasing a liquefied gas, triggering a chemicalreaction, or the like.

FIGS. 4-6 are schematic illustrations of a medicament delivery device2000 according to an embodiment. The medicament delivery device 2000includes a housing 2100, an energy storage member 2410, a carrier 2360,and a medicament container assembly 2200. The housing 2100 contains theenergy storage member 2410, the carrier 2360, and at least a portion ofthe medicament container assembly 2200. The housing 2100 can be anysuitable size, shape, or configuration. As shown, the housing 2100 hashousing length H_(L) defined along a longitudinal axis AL of thehousing. Moreover, the housing 2100 can be made of any suitablematerial. For example, in some embodiments, the housing 2100 is anassembly of multiple parts formed from a plastic material and defines asubstantially rectangular shape when assembled. In other embodiments,the housing 2100 can have a substantially cylindrical shape.

The energy storage member 2410 is disposed within the housing 2100, andis configured to produce a force F (see FIGS. 5 and 6 ) to convey thecontents of the medicament container assembly 2200 when the energystorage member 2410 is actuated to release a potential energy storedtherein. The energy storage member 2410 can be any suitable member ordevice that stores potential energy and, when actuated, releases theenergy to produce a force. For example, the energy storage member 2410(and any of the energy storage members described herein) can be any of agas container, a chemical energy storage member, a spring, a magnetic,or an electrical energy storage member.

The medicament container assembly 2200 has a container body 2210 thatdefines a volume that contains (i.e., is filled with or partially filledwith) a medicament. The distal end portion of the medicament containerbody 2210 includes a needle 2216 through which the medicament can bedelivered. The needle 2216 can be any suitable needle having anysuitable diameter and length. For example, in some embodiments, theneedle 2216 is a 29-gauge needle having a length of approximately 0.5inches. In some embodiments, the medicament container assembly 2200 canbe a prefilled syringe having the needle 2216 staked thereto. As shownin FIG. 4 , the medicament container assembly has a length L_(C) (fromthe flange to the distal tip of the needle 2216).

The medicament container assembly 2200 includes an elastomeric member2217 (i.e., a plunger) that seals the medicament within the containerbody 2210. The elastomeric member 2217 is configured to move within thecontainer body to inject the medicament from the medicament containerassembly 2200. The elastomeric member 2217 can be of any design orformulation suitable for contact with the medicament. For example, theelastomeric member 2217 can be formulated to minimize any reduction inthe efficacy of the medicament that may result from contact (eitherdirect or indirect) between the elastomeric member 2217 and themedicament. For example, in some embodiments, the elastomeric member2217 can be formulated to minimize any leaching or out-gassing ofcompositions that may have an undesired effect on the medicament. Inother embodiments, the elastomeric member 2217 can be formulated tomaintain its chemical stability, flexibility and/or sealing propertieswhen in contact (either direct or indirect) with the medicament over along period of time (e.g., for up to six months, one year, two years,five years or longer).

The carrier 2360 is movably disposed within the housing, and isconfigured to be coupled to the medicament container assembly 2200. Thecarrier 2360 can be coupled to the medicament container assembly 2200 inany suitable manner. For example, as shown, in some embodiments, thecarrier 2360 can define an opening within which a portion of thecontainer body 2210 can be received. The carrier 2360 can define, forexample, a shoulder, protrusion, or other structure that couples to aportion of the container body 2210 (e.g., a flange, a side wall or thelike). In other embodiments, the carrier 2360 can surround only aportion of the container body 2210. In yet other embodiments, thecarrier 2360 can be constructed from multiple components that are joinedtogether (e.g., via a hinged joint, a mechanical fastener or the like)to surround and/or be coupled to the medicament container assembly 2200.

The carrier 2360 includes a proximal surface 2376 upon which a force Fproduced by the energy storage member 2410 can act. In this manner, whenthe medicament delivery device 2000 is actuated, the carrier 2360 moveswithin the housing 2100 from a first carrier position (FIG. 4 ) to asecond carrier position (FIG. 5 ). As shown in FIG. 5 , movement of thecarrier 2360 in the distal direction moves the medicament containerassembly 2200 in a like manner and distance. Specifically, when thecarrier 2360 is in the first carrier position (FIG. 4 ), the needle 2216is in a first needle position, in which the needle 2216 is disposedwithin the housing 2100. When the carrier 2360 is in the second carrierposition (FIG. 5 ), the needle 2216 is in a second needle position, inwhich a portion of the needle 2216 is disposed outside of the housing2100. The length of the exposed portion of the needle 2216 is dependenton the distance the carrier 2360 moves. As shown in FIG. 5 , thedistance between the first carrier position and the second carrierposition (the carrier distance) is L_(CAR).

After the carrier 2360 is in the second carrier position (and the needle2216 is exposed), continued application of the force F from the energystorage member 2410 causes movement of the elastomeric member 2217within the container body 2210. In the manner, the medicament can beexpelled from the container body 2210. Similarly stated, when theproximal surface 2218 of the elastomeric member 2217 is exposed to theforce F movement of the elastomeric member 2217 conveys the medicamentfrom the container body 2210.

Moreover, the medicament container assembly 2200 and the energy storagemember 2410 can be collectively configured such that the elastomericmember 2217 travels a desired distance within the container body 2210during a delivery event. This distance is referred to as the “stroke,”and is shown as L_(ST) in FIG. 6 . In some embodiments, the travel ofthe elastomeric member 2217 can be controlled or limited by deactivatingthe energy storage member 2410 (e.g., for an electronic- ormagnetic-based energy storage member). In other embodiments, the travelof the elastomeric member 2217 can be controlled or limited by releasinga pressure from within the housing 2100, similar the gas vent mechanismsdescribed herein. In this manner, the medicament delivery device 2200can be configured to provide a desired fill volume and delivery volume.For example, in some embodiments the medicament container assembly 2200can be a prefilled syringe and can be purchased and/or acquired with agiven fill volume.

In some embodiments, the device 2000 is configured as a compact devicesuch that a ratio of the housing length H_(L) to the container lengthH_(C) is less than about 1.5. In other embodiments, the device 2000 isconfigured such that a ratio of the housing length H_(L) to thecontainer length H_(C) is less than about 1.25. In yet otherembodiments, the device 2000 is configured such that a ratio of thehousing length H_(L) to the container length H_(C) is less than about1.1.

In some embodiments, the device 2000 is configured as a compact devicesuch that a ratio of the housing length H_(L) to a sum of the containerlength H_(C), the carrier distance L_(CAR), and the stroke L_(ST) isless than about 1.1. In other embodiments, the device 2000 is configuredsuch that a ratio of the housing length H_(L) to a sum of the containerlength H_(C), the carrier distance L_(CAR,) and the stroke L_(ST) isless than about 1.0. In yet other embodiments, the device 2000 isconfigured such that a ratio of the housing length H_(L) to a sum of thecontainer length H_(C), the carrier distance L_(CAR), and the strokeL_(ST) is less than about 0.9.

In some embodiments, the medicament delivery device 2000 includes aretraction mechanism coupled to any one of the carrier 2360 or themedicament container assembly 2200 to retract the needle 2216 back intothe housing 2100 after delivery of the medicament. For example, in someembodiments, the medicament delivery device 2000 includes a spring (notshown) that moves the carrier 2360, and thus the medicament containerassembly 2200 back towards the first needle position after delivery ofthe medicament.

In some embodiments, the carrier 2360 (and any of the carriers shown anddescribed herein) can include one or more seals to facilitate movementwithin the housing while also maintaining isolation of an internalvolume of the housing. For example, in some embodiments, a carrier caninclude a seal to maintain a pressurized gas chamber during a deliveryevent. In this manner, high pressures can be employed to deliver a rangeof volumes of a variety of medicaments (having a wide range ofviscosity). FIGS. 7 and 8 are schematic illustrations of a medicamentdelivery device 3000 according to an embodiment. The medicament deliverydevice 3000 includes a housing 3100, an energy storage member 3410, acarrier 3360, and a medicament container assembly 3200. The housing 3100defines a gas chamber 3139 that receives a pressurized gas from theenergy storage member 3410. The gas chamber 3139 can be of any suitablesize and shape, and can be, for example, a portion of the volume definedby the housing 3100 within which a portion of the medicament containerassembly 3200 and/or the carrier 3360 is disposed. Although not shown,in some embodiments, the housing includes a vent mechanism, such as anopening or valve, of the types shown and described herein (e.g., withrespect to the device 1000 and the device 4000). In this manner, the gaspressure within the gas chamber 3139 can be reduced upon completion ofthe injection event.

The housing 3100 can be any suitable size, shape, or configuration andcan be made of any suitable material. For example, in some embodiments,the housing 3100 is an assembly of multiple parts formed from a plasticmaterial and defines a substantially rectangular shape when assembled.In other embodiments, the housing 3100 can have a substantiallycylindrical shape.

The energy storage member 3410 is disposed within the housing 3100, andis configured to produce a force F (see FIGS. 5 and 6 ) to convey thecontents of the medicament container assembly 3200 when the energystorage member 3410 is actuated to release a potential energy storedtherein. The energy storage member 3410 can be any suitable member ordevice that stores potential energy and, when actuated, releases theenergy to produce a force. For example, the energy storage member 3410(and any of the energy storage members described herein) can be any of agas container, a chemical energy storage member, a spring, a magnetic,or an electrical energy storage member.

The medicament container assembly 3200 has a container body 3210 thatdefines a volume that contains (i.e., is filled with or partially filledwith) a medicament. The distal end portion of the medicament containerbody 3210 includes a needle 3216 through which the medicament can bedelivered. The needle 3216 can be any suitable needle having anysuitable diameter and length. For example, in some embodiments, theneedle 3216 is a 39-gauge needle having a length of approximately 0.5inches. In some embodiments, the medicament container assembly 3200 canbe a prefilled syringe having the needle 3216 staked thereto.

The medicament container assembly 3200 includes an elastomeric member3217 (i.e., a plunger) that seals the medicament within the containerbody 3210. The elastomeric member 3217 is configured to move within thecontainer body to inject the medicament from the medicament containerassembly 3200. The elastomeric member 3217 can be of any design orformulation suitable for contact with the medicament. For example, theelastomeric member 3217 can be formulated to minimize any reduction inthe efficacy of the medicament that may result from contact (eitherdirect or indirect) between the elastomeric member 3217 and themedicament. For example, in some embodiments, the elastomeric member3217 can be formulated to minimize any leaching or out-gassing ofcompositions that may have an undesired effect on the medicament. Inother embodiments, the elastomeric member 3217 can be formulated tomaintain its chemical stability, flexibility and/or sealing propertieswhen in contact (either direct or indirect) with the medicament over along period of time (e.g., for up to six months, one year, two years,five years or longer).

The carrier 3360 is disposed within the housing, and is configured to becoupled to a medicament container assembly 3200. The carrier 3360 can becoupled to the medicament container assembly 3200 in any suitablemanner. For example, as shown, in some embodiments, the carrier 3360 candefine an opening within which a portion of the container body 3210 canbe received. The carrier 3360 can define, for example, a shoulder,protrusion, or other structure that couples to a portion of thecontainer body 3210 (e.g., a flange, a side wall or the like). In otherembodiments, the carrier 3360 can surround only a portion of thecontainer body 3210. In yet other embodiments, the carrier 3360 can beconstructed from multiple components that are joined together (e.g., viaa hinged joint, a mechanical fastener or the like) to surround and/or becoupled to the medicament container assembly 3200.

The carrier 3360 includes a proximal surface 3376 that defines a portionof a boundary of the gas chamber 3139. In this manner, when apressurized gas P (see FIG. 8 ) is conveyed into the gas chamber 3139,the pressure therein will produce a force on the proximal surface 3376and/or the elastomeric member 3217. In this manner, when the medicamentdelivery device 3000 is actuated, the carrier 3360 moves within thehousing 3100 from a first carrier position (FIG. 7 ) to a second carrierposition (FIG. 8 ). As shown in FIG. 8 , movement of the carrier 3360 inthe distal direction moves the medicament container assembly 3200 in alike manner and distance. Specifically, when the carrier 3360 is in thefirst carrier position (FIG. 7 ), the needle 3216 is in a first needleposition, in which the needle 3216 is disposed within the housing 3100.When the carrier 3360 is in the second carrier position (FIG. 8 ), theneedle 3216 is in a second needle position, in which a portion of theneedle 3216 is disposed outside of the housing 3100.

As shown, the carrier 3360 includes a first seal member 3370 and asecond seal member 3371. The first (or outer) seal member 3370 is insliding contact with an inner surface of the housing 3100 to fluidicallyisolate the gas chamber 3139 from an exterior volume. Similarly stated,the outer seal member 3370 is configured to form a substantially fluidtight seal with the inner surface of the housing 3100 defining the gaschamber (or medicament cavity) 3139. The first seal member 3370 can beany suitable seal, such as an O-ring, a strip seal or the like.

The second seal member 3371 is in contact with a proximal end portion ofthe container body 3210. For example, in some embodiments, the second(or inner) seal member 3371 is disposed between an inner surface of aflange of the container body 3210 and a shoulder of the carrier 3360.The inner seal member 3371 forms a substantially fluid tight sealbetween the container body 3210 and the carrier 3360. In this manner,the fluid leakage paths associated with (or caused by) the medicamentcontainer within the housing 3100 can be minimized.

As shown in FIG. 7 , the first seal member 3370 is spaced apart from thesecond seal member 3371 by a distance Dseai. In some embodiments, thecarrier 3360 is constructed such that the first seal member 3370 remainsin a fixed position relative to the second seal member 3371 during use.Although the second seal member 3371 is shown as being disposed distallyfrom the first seal member 3370, in other embodiments, the second sealmember 3371 can be longitudinally aligned with, or disposed proximallyfrom, the first seal member 3370.

In some embodiments, a medicament delivery can be an auto-injectorhaving a pistonless delivery system in which the force exerted by thegas can move the medicament container relative to the housing and theelastomeric member relative to (e.g., within) the medicament container.For example, FIGS. 9-43 show a medical injector 4000 (also referred toas “auto-injector,” “injector,” or “device”), according to anembodiment. The medical injector 4000 is a gas-powered auto-injectorconfigured to deliver a medicament contained within a prefilled syringe4200, as described herein. A discussion of the components of the medicalinjector 4000 will be followed by a discussion of the operation of themedical injector 4000. Certain aspects of the medical injector 4000 canbe similar to or substantially the same to the medical injectorsdescribed in U.S. patent application Ser. No. 13/357,935 (now U.S. Pat.No. 9,084,849) entitled, “MEDICAMENT DELIVERY DEVICES FOR ADMINISTRATIONOF A MEDICAMENT WITHIN A PREFILLED SYRINGE,” filed on Jan. 25, 2012(referred to henceforth as the “'849 patent”), the disclosure of whichis incorporated herein by reference in its entirety.

The medical injector 4000 includes a housing 4100 (see e.g., FIGS. 12-13), a system actuation assembly 4500 (see e.g., FIGS. 16-17 ), amedicament container assembly 4200 (see FIG. 26 ), a medicament deliverymechanism 4300 (see e.g., FIGS. 22-29 ), a base 4510 (or actuator, seeFIGS. 32 and 33 ); and a safety lock 4700 (see FIGS. 30-31 ). As shownin FIGS. 12-13 , the housing 4100 has a proximal end portion 4101 and adistal end portion 4102. The housing 4100 defines a first statusindicator aperture 4130 and a second status indicator aperture 4160. Thefirst status indicator aperture 4130 defined by the housing 4100 islocated on a first side of the housing 4100, and the second statusindicator aperture 4160 of the housing 4100 is located on a second sideof the housing 4100. The status indicator apertures 4130, 4160 can allowa patient to monitor the status and/or contents of the medicamentcontainer 4200, the carrier 4360, and the medicament contained withinthe housing 4100. For example, by visually inspecting the statusindicator apertures 4130, 4160, a patient can determine whether themedicament container 4200 contains a medicament and/or whether themedicament has been dispensed.

In some embodiments, the housing 4100 can include a label or indiciathat mask or otherwise accentuates the status indicator apertures 4130,4160 and/or the contents viewed therethrough. For example, in someembodiments, the housing 4100 can include a label (not shown) havingborder that surrounds at least a portion of the status indicatoraperture 4130, the status indicator apertures 4160 (or both). In someembodiments, a label can include indicator colors that alert user (orassist a user in determining) whether the medicament is properlycolored, whether a portion of the carrier 4360 is visible through thewindow or the like.

As shown in FIGS. 12 and 13 , the housing 4100 defines a gas containercavity 4151 and a medicament cavity 4139. The gas container cavity 4151is configured to receive the gas container 4410 and a portion of thesystem actuator assembly 4500 (e.g., a release member 4550 and thespring 4576, as shown in FIGS. 16 and 17 ). The proximal end portion4152 of the gas container cavity 4151 is configured to receive the gascontainer retention member 4580 of a proximal cap 4103 of the housing4100, as described in further detail herein. The gas container cavity4151 is in fluid communication with the medicament cavity 4139 via a gaspassageway (not shown), as described in further detail herein.

The medicament cavity 4139 is configured to receive the medicamentcontainer assembly 4200 and at least a portion of the medicamentdelivery mechanism 4300. In particular, as described below, themedicament delivery mechanism 4300 includes a carrier assembly 4390 anda gas vent assembly 4310 movably disposed in the medicament cavity 4139.The medicament cavity 4139 is in fluid communication with a regionoutside the housing 4100 via a needle aperture 4105 (see e.g., FIGS. 45and 46 ) and also a vent opening 4112.

The proximal end portion 4101 of the housing 4100 includes a proximalcap 4110 (see e.g., FIGS. 14, 15 and 20 ). The proximal cap 4110includes a gas container retention member 4180 and defines a gaspassageway between the medicament cavity 4139 and the gas containercavity 4151. The gas container retention member 4180 is configured toreceive and/or retain a gas container 4410 that contains a pressurizedgas, as shown in FIGS. 16 and 17 . When the medical injector 4000 isactuated, pressurized gas from the gas container 4410 is conveyed fromthe gas container cavity 4151 to the medicament cavity 4139 via the gaspassageway. Said another way, the gas passageway places the gascontainer cavity 4151 in fluid communication with the medicament cavity4139. Thus, the proximal portion of the medicament cavity 4139 can bereferred to as a gas chamber. Similarly stated, the proximal portion ofthe medicament cavity 4139 is a volume within which a pressurized gas isconveyed to move the carrier 4360 and inject the medicament, asdescribed herein.

The proximal cap 4110 also includes an O-ring 4113 and defines the ventopening 4112. As described herein, the vent opening 4112 provides thepassageway through which pressurized gas is conveyed from the medicamentcavity 4139 (or gas chamber portion of the medicament cavity 4139) to avolume outside of the medical injector 4000. In this manner, the forceproduced by the pressurized gas on the medicament delivery mechanism4300 and/or the medicament container assembly 4200 can be reduced toallow needle retraction after the injection is completed. As shown inFIG. 20 , the O-ring 4113, in conjunction with the valve portion 4345 ofthe gas vent assembly 4310, selectively seals the vent opening 4112during needle insertion and delivery of the medicament.

Although the vent opening 4112 is shown as being defined by the proximalcap 4110, and being in a proximal surface thereof, in other embodiments,the vent opening 4112 (and any of the vent openings described herein,including the vent opening 8112) can be defined within any suitableportion of the proximal cap or side wall. For example, in someembodiments, the vent opening 4112 (and any of the vent openingsdescribed herein, including the vent opening 8112) can be defined by theproximal cap, but can have a centerline that is nonparallel to alongitudinal axis of the medical injector 4000. Said another way, insome embodiments, the vent opening 4112 (and any of the vent openingsdescribed herein, including the vent opening 8112) can open towards aside of the medical injector, rather than opening towards the proximalend, as shown. In other embodiments, the vent opening 4112 (and any ofthe vent openings described herein, including the vent opening 8112) canbe defined by any wall and/or surface of the housing 4100.

The proximal cap 4110 includes a guide wall 4115 within which the first(or proximal) member 4340 of the gas vent assembly 4310 moves.Specifically, the guide wall defines a pair of slots 4116 within whichthe guide surface 4344 of the first member 4340 (see e.g., FIGS. 27, 28) slide during operation. The guide wall 4115 also includes an endsurface 4117 against which a flange 4214 of the container body 4210rests when the medical injector 4000 is in its first configuration(i.e., the “storage” state).

As shown in FIG. 13 , the distal end portion 4102 of the housing 4100includes a shoulder 4106 and defines a needle aperture 4105. The distalend portion 4102 also includes base rail grooves 4114 and base retentionrecesses 4134 (see FIG. 12 ). The shoulder 4106 is configured to contacta corresponding surface 4365 of the carrier body 4360 (see e.g., FIG. 20) when the needle 4216 has been inserted a desired distance. In thismanner the shoulder 4016 can act as an “end stop” or insertion limitingmechanism. The needle aperture 4105 is the opening through which theneedle 4216 is disposed when the medical injector 4000 is actuated, asdescribed in further detail herein.

The distal end portion 4102 of the housing also include a release membercontact surface 4126, and defines the release member aperture. As shownin FIG. 21 , the release member aperture 4145 receives a distal endportion 5152 of a release member 4550, such that the extensions 4553 ofthe release member 4550 engage with the release member contact surfaceto prevent activation of the medical injector 4000. The safety lock4700, its components and functions are described in more detail below.

The distal base retention recesses 4134 are configured to receive thebase connection knobs 4518 of the actuator 4510 (also referred to hereinas “base 4510,” see e.g., FIGS. 32 and 33 ) when the base 4510 is in afirst position relative to the housing 4100. The proximal-most pair ofbase retention recesses 4134 are configured to receive the baseconnection knobs 4518 of the base 4510 when the base 4510 is in a second(i.e., actuated) position relative to the housing 4100. The baseretention recesses 4134 have a tapered proximal sidewall and anon-tapered distal sidewall. This allows the base retention recesses4134 to receive the base connection knobs 4518 such that the base 4510can move proximally relative to the housing 4100, but cannot movedistally relative to the housing 4100. Said another way, the distal-mostset of base retention recesses 4134 are configured to prevent the base4510 from moving distally when the base 4510 is in a first position andthe proximal-most set of base retention recesses 4134 are configured toprevent the base 4510 from moving distally when the base 4510 is in asecond position. Similarly stated, the proximal base retention recesses4134 and the base connection knobs 4518 cooperatively to limit movementof the base to prevent undesirable movement of the base 4510 after themedical injector 4000 is actuated. The proximal base retention recesses4134 and the base connection knobs 4518 also provide a visual cue to theuser that the medical injector 4000 has been used.

The base rail grooves 4114 receive the guide members 4517 of the base4510 (see FIGS. 32 and 33 ). The guide members 4517 of the base 4510 andthe base rail grooves 4114 of the housing 4100 engage each other in away that allows the guide members 4517 of the base 4510 to slide in aproximal and/or distal direction within the base rail grooves 4114 whilelimiting lateral movement of the guide members 4517. This arrangementallows the base 4510 to move in a proximal and/or distal direction withrespect to the housing 4100 but prevents the base 4510 from moving in alateral direction with respect to the housing 4100.

FIGS. 16-17 provide an overview of the medicament container assembly4200, the system actuator assembly 4500, and the medicament deliverymechanism 4300 of the medical injector 4000. Referring to FIG. 26 , themedicament container assembly 4200 has a container body 4210 with adistal end portion 4213 and a proximal end portion 4212. The containerbody 4210 defines a volume that contains (i.e., is filled with orpartially filled with) a medicament. The distal end portion 4213 of themedicament container assembly 4200 includes a neck that is coupled tothe needle 4216, as described below. The proximal end portion 4212 ofthe medicament container assembly 4200 includes an elastomeric member4217 (i.e., a plunger) that seals the medicament within the containerbody 4210. The elastomeric member 4217 is configured to move within thecontainer body to inject the medicament from the medicament containerassembly 4200.

More particularly, as shown in FIG. 20 , the elastomeric member 4217includes a proximal surface 4218 and is coupled to the distal member4320 of the gas venting assembly 4310. In this manner, as describedbelow, when the pressurized gas is conveyed into the medicament cavity4139 (or “gas chamber”), the pressure exerts a force on the proximalsurface 4218 to move the elastomeric member 4217 within the containerbody 1210 (i.e., to expel the medicament therefrom). Further, becausethe elastomeric member 4217 is coupled to the gas venting assembly 4310,movement of the elastomeric member 4217 within the container body 4210produces movement of at least a portion of the distal member 4320.Similarly stated, when the elastomeric member 4217 is exposed to a force(e.g., produced by the pressurized gas within the gas chamber 4139acting directly on the proximal surface 4218), movement of theelastomeric member 4217 exerts a force on the distal member 4320.Specifically, distal movement of the elastomeric member 4217 can producea tensile force on the distal member

The distal member 4320 can be coupled to the elastomeric member 4217 inany suitable manner. For example, as shown, the proximal surface 4218receives and/or couples to a protrusion 4323 of the distal member 4320of the gas venting assembly 4310. In other embodiments, the distalmember 4320 can be threadedly coupled to the elastomeric member 4217. Inyet other embodiments, the distal member 4320 can be bonded to theelastomeric member 4217 via an adhesive, a weld process, or the like

The elastomeric member 4217 can be of any design or formulation suitablefor contact with the medicament. For example, the elastomeric member4217 can be formulated to minimize any reduction in the efficacy of themedicament that may result from contact (either direct or indirect)between the elastomeric member 4217 and the medicament. For example, insome embodiments, the elastomeric member 4217 can be formulated tominimize any leaching or out-gassing of compositions that may have anundesired effect on the medicament. In other embodiments, theelastomeric member 4217 can be formulated to maintain its chemicalstability, flexibility and/or sealing properties when in contact (eitherdirect or indirect) with the medicament over a long period of time(e.g., for up to six months, one year, two years, five years or longer).

In some embodiments, the elastomeric member 4217 can be constructed frommultiple different materials. For example, in some embodiments, at leasta portion of the elastomeric member 4217 can be coated. Such coatingscan include, for example, polydimethylsiloxane. In some embodiments, atleast a portion of the elastomeric member 4217 can be coated withpolydimethylsiloxane in an amount of between approximately 0.02 mg/cm²and approximately 0.80 mg/cm².

The proximal end portion 4212 of the container body 4210 includes aflange 4214 configured to be disposed within a portion of the carrierbody 4360, as described in further detail herein. The flange 4214 can beof any suitable size and/or shape. Although shown as substantiallycircumscribing the container body 4210, in other embodiments, the flange4214 can only partially circumscribe the container body 4210.

The medicament container assembly 4200 can have any suitable size (e.g.,length and/or diameter) and can contain any suitable volume of themedicament. In some embodiments, the medicament container assembly 4200(and any of the medicament container assemblies described herein) can bea prefilled (or prefillable) syringe, such as those manufactured byBecton Dickinson, Gerresheimer, Ompi Pharma or others. For example, insome embodiments, the medicament container assembly 4200 (and any of themedicament container assemblies described herein) can be a BectonDickinson “BD Hypak Physiolis” prefillable syringe containing any of themedicaments described herein. The medical injector 4000 can beconfigured to inject any suitable dosage such as, for example, a dose ofup to 4 mL of any of the medicaments described herein. In otherembodiments, the medical injector 4000 can be configured to inject adose of up to 2 mL, 3 mL, 4 mL, 5 mL, or more of any of the medicamentsdescribed herein.

The container body 4210 can be constructed from glass, and can be fittedand/or coupled to any suitable needle. For example, in some embodiments,the container body 4210 can be coupled to a needle having any suitablesize. Any of the medicament container assemblies and/or prefilledsyringes described herein can be coupled to a needle having a gauge sizeof 21 gauge, 22 gauge, 23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge,28 gauge, 29 gauge, 30 gauge, or 31 gauge. Any of the medicamentcontainer assemblies and/or prefilled syringes described herein can becoupled to a needle having any suitable length, such as, for example, alength of about 0.2 inches, about 0.27 inches, about 0.38 inches, about0.5 inches, about 0.63 inches, about 0.75 inches, or more. In someembodiments, for example, any of the medicament containers and/orprefilled syringes described herein can be coupled to a 29 gauge, needlehaving a length of approximately 0.5 inches.

As shown in FIG. 26 , the medicament container assembly 4200 includes aneedle sheath assembly 4220, that includes a sheath body 4230 and asheath cover 4235. The needle sheath assembly 4220 includes a distal endportion 4221 and a proximal end portion 4222. The sheath body 4230defines a bore that receives the needle 4216 and/or a distal end portionof the 4213 of the medicament container body 4210. The inner portion ofthe sheath body 4230 defines a friction fit with the distal end portion4213 of the medicament container body 4210. In this manner, the needlesheath assembly 4220 can protect the user from the needle 4216 and/orcan keep the needle 4216 sterile before the user actuates the medicalinjector 4000.

The sheath cover 4235 is disposed about (and surrounds) the sheath body4230. The sheath cover 4235 includes a series of ribs 4236 that engagethe tabs 4722 of the safety lock 4700 (see e.g., FIGS. 19 and 21 ).Specifically, the distal end portion 4812 of the sheath assembly 4220 isconfigured to be inserted into a space defined between the tabs 4722 ofthe engagement members 4721 of the safety lock 4700. The tabs 4722 areangled and/or bent towards the distal direction to allow the distal endportion 4812 of the sheath assembly 4220 to move between the engagementmembers 4721 in a distal direction, but not in a proximal direction.Similarly stated, the tabs 4722 include an edge that contacts the ribs4236 of the sheath cover 4235 to prevent the safety lock 4700 frommoving in a distal direction relative to the needle sheath 4810. In thismanner, the needle sheath assembly 4220 is removed from the needle 4216when the safety lock 4700 is moved in a distal direction with respect tothe housing 4100.

The delivery mechanism 4300 includes a gas vent assembly 4310 (alsoreferred to as an expandable assembly), but does not rely on a piston orrigid member to move the elastomeric member 4217 within the containerbody 4210 to inject the medicament. Rather, the elastomeric member 4217is moved by the force produced by the pressurized gas within the gaschamber (or medicament cavity 4139). Accordingly, the stroke lengthand/or the dosage amount can be set by the expanded length of the gasvent assembly 4310. In this manner, the length of the medicamentcontainer assembly 4200 and the length of the gas vent assembly 4310 canbe configured such the desired dosage amount is delivered. Moreover,because the gas vent assembly 4310 moves from a collapsed to an expandedconfiguration, the medicament delivery mechanism 4300 can fit within thesame housing 4100 regardless of the fill volume, the delivery volumeand/or the ratio of the fill volume to the delivery volume. In thismanner, the same housing and production tooling can be used to producedevices having various dosages of the medicament. For example, in afirst embodiment (e.g., having a fill volume to delivery volume ratio of0.4), the medicament container has a first length and the second movablemember has a first length. In a second embodiment (e.g., having a fillvolume to delivery volume ratio of 0.6), the medicament container has asecond length shorter than the first length, and the second movablemember has a second length longer than the first length. In this manner,the stroke of the device of the second embodiment is longer than that ofthe device of the first embodiment, thereby allowing a greater dosage.The medicament container of the device of the second embodiment,however, is shorter than the medicament container of the device of thefirst embodiment, thereby allowing the components of both embodiments tobe disposed within the same housing and/or a housing having the samelength.

In some embodiments, the device 4000 is configured such that a ratio ofthe housing length H_(L) to the container length H_(C) is less thanabout 1.5. In other embodiments, the device 4000 is configured such thata ratio of the housing length H_(L) to the container length H_(C) isless than about 1.25. In yet other embodiments, the device 4000 isconfigured such that a ratio of the housing length H_(L) to thecontainer length H_(C) is less than about 1.1.

In some embodiments, the device 4000 is configured such that a ratio ofthe housing length H_(L) to a sum of the container length H_(C), thecarrier distance, and the stroke is less than about 1.1. In otherembodiments, the device 4000 is configured such that a ratio of thehousing length H_(L) to a sum of the container length H_(C), the carrierdistance, and the stroke is less than about 1.0. In yet otherembodiments, the device 4000 is configured such that a ratio of thehousing length H_(L) to a sum of the container length H_(C), the carrierdistance, and the stroke is less than about 0.9.

As shown in FIGS. 16, 17 and 34 , the system actuator assembly 4500includes the base 4510, a release member 4550 and a spring 4576. FIG. 17shows certain internal components of the medical injector 4000 withoutthe base 4510 and the safety lock 4700 so that the release member 4550can be more clearly shown. The release member 4550 has a proximal endportion 4551 and a distal end portion 4552, and is movably disposedwithin the distal end portion of the gas container cavity 4151. Theproximal end portion of the release member 4550 includes a sealingmember 4574 and a puncturer 4575. The sealing member 4574 is configuredto engage the sidewall of the housing 4100 defining the gas containercavity 4151 such that the proximal end portion of the gas containercavity 4151 is fluidically isolated from the distal end portion of thegas container cavity 4151. In this manner, when gas is released from thegas container 4410, the gas contained in the proximal end portion of thegas container cavity 4151 is unable to enter the distal end portion ofthe gas container cavity 4151. The puncturer 4575 of the release member4550 is configured to contact and puncture a frangible seal 4413 on thegas container 4410 when the release member 4550 moves proximally withinthe gas container cavity 4151.

The distal end portion 4552 of the release member 4550 includesextensions 4553. The extensions 4553 have projections that includetapered surfaces and engagement surfaces. Further, the extensions 4553define an opening between the adjacent extensions 4553. The engagementsurfaces are configured to extend through the release member apertureand contact the release member contact surface of the housing 4100, asshown in FIG. 34 . In this manner, the engagement surfaces limitproximal movement of the release member 4550.

The opening defined by the extensions 4553 is configured to receive thesafety lock protrusion 4702 of the safety lock 4700 (see e.g., FIGS. 19and 21 ) when the safety lock 4700 is coupled to the housing 4100 and/orthe base 4510. The safety lock protrusion 4702 is configured to preventthe extensions 4553 from moving closer to each other. Said another way,the safety lock protrusion 4702 is configured to ensure that theextensions 4553 remain spaced apart and the engagement surfaces remainin contact with the release member contact surface of the housing 4100.In some embodiments, for example, the release member 4550 and/or theextensions 4553 can be constructed from any suitable material configuredto withstand deformation that may occur when exposed to a load over anextended period of time.

The tapered surfaces of the extensions 4553 are configured to contactcorresponding tapered surfaces 4557 of the base 4510 when the base 4510is moved proximally relative to the housing 4100. Accordingly, when thebase 4510 is moved proximally relative to the housing 4100, theextensions 4553 are moved together by the tapered surfaces. The inwardmovement of the extensions 4553 causes the release member 4550 todisengage the release member contact surface 4126 of the housing 4100,thereby allowing the release member 4550 to be moved proximally alongits longitudinal axis as the spring 4576 expands (see FIG. 37 ).

The gas container 4410 includes a distal end portion 4411 and a proximalend portion 4412, and is configured to contain and/or produce apressurized gas. The distal end portion 4411 of the gas container 4410contains a frangible seal 4413 configured to break when the puncturer4575 of the release member 4550 contacts the frangible seal 4413. Thegas container retention member 4180 of the proximal cap 4110 of thehousing 4100 is configured to receive and/or retain the proximal endportion 4412 of the gas container 4410. Said another way, the positionof the gas container 4410 within the gas container cavity 4151 ismaintained by the gas container retention member 4180. As shown in FIGS.16 and 17 , the length of the gas container retention member 4180 andthe length of the release member 4550 collectively determine thedistance between the puncturer 4575 and the frangible seal 4413 when themedical injector 4000 is in the storage configuration. Accordingly, thisdistance, which is the distance through which the puncturer 4575 travelswhen the medical injector 4000 is actuated, can be adjusted by changingthe length of the gas container retention member 4180 and/or the lengthof the release member 4550. In some embodiments, the actuation timeand/or the force exerted by the puncturer 4575 on the frangible seal4413 can be adjusted by changing the distance between the puncturer 4575and the frangible seal 4413.

The medicament delivery mechanism 4300 includes a carrier assembly 4390and a gas vent assembly 4310. The carrier assembly 4390 and the gas ventassembly 4310 are each movably disposed within the medicament cavity4139 of the housing 4100. As shown in FIGS. 22-24 , the carrier assembly4390 includes a carrier body 4360 and a retraction spring 4380. Thecarrier body 4360 includes a proximal end portion 4362 and a distal endportion 4361. The proximal end portion 4362 of the carrier body 4360defines an opening within which the medicament container body 4210 isdisposed. The proximal end portion 4362 also includes a proximal surface4376, forms a portion of the boundary of the gas chamber (i.e., theportion of the medicament cavity 1139 within which the pressurized gasflows). In this manner, the pressurized gas produces a force on theproximal surface 4376, which moves the carrier assembly 4390 distallywithin the housing 4110.

An inner surface of the proximal end portion 4362 defines a groovewithin which a first O-ring 4371 and a second O-ring 4372 are disposed.The first O-ring 4371 and the second 0-ring 4372 are disposed between atop surface of the carrier body 4360 and the flange 4214 of themedicament container body 4210. In this manner, the first O-ring 4371and the second O-ring 4372 form a substantially fluid-tight seal.Accordingly, when pressurized gas flows into the proximal portion of themedicament cavity 4139 (i.e., the gas chamber), the area between theinner surface of the carrier body 4360 and the medicament container body4210 is sealed. The first O-ring 4371 and the second O-ring 4372 alsodampen any impact on the flange 4214.

An outer surface of the carrier body 4360 defines an O-ring groove andincludes an outer O-ring 4370. The outer surface is configured to slidewithin the medicament cavity 4139, and the O-ring 4370 and an innersurface of the housing 4100 define a form a substantially fluid-tightseal. Accordingly, when pressurized gas flows into the proximal portionof the medicament cavity 4139, the area between the outer surface of thecarrier body 4360 and the inner surface of the housing 4100 is sealed.The outer O-ring 4370 is in a fixed location relative to each of theinner O-rings 4371, 4372. In other embodiments, however, a carrierassembly can include components that move relative to each other suchthat an outer seal member moves relative to an inner seal member.

The distal end portion 4361 of the carrier body 4360 has an open end.Thus, as shown in FIGS. 24 and 25 , the distal end portion 4213 of themedicament container body 4210 extends beyond the carrier body 4360.Additionally, the distal end portion 4361 of the carrier body 4360includes two extensions (or “legs”) that collectively define an opening4375. This opening is configured to align with the status apertures4130, 4160 of the housing to allow viewing of the medicament within themedicament container assembly, the elastomeric member 4217 or the like.The distal end portion 4361 also includes an end surface 4365 configuredto contact the shoulder 4106 of the housing 4100 (see e.g., FIG. 37 )when the needle 4216 has been inserted a desired distance.

The retraction spring 4380 is disposed within a spring pocket 4363defined by the outer surface of the carrier body 4360, as shown in FIG.24 . The retraction spring 4380 is disposed about a spring pin 4381 thatlimits buckling or other lateral movement of the retraction spring 4380during use.

The gas vent assembly 4310 is configured to expand and/or changeconfigurations during operation of the medical injector 4100, andselectively produces a pathway through which pressurized gas escapes themedicament cavity 4139 after delivery of the medicament. By releasing orremoving the force from the carrier body 4360 and/or the medicamentcontainer assembly 4200, the retraction spring 4380 can move the carrierbody 4360 proximally to retract the needle 4216. Notably, the gas ventassembly 4310 does not exert a distal force on the elastomeric member4217, but rather, is carried distally by the elastomeric member 4217during delivery of the medicament. Thus, this arrangement is considereda “pistonless” delivery system, because the force for insertion andmedicament delivery is provided by the pressurized gas acting directlyupon the medicament container assembly 4200 (e.g., the proximal surface4218 of the elastomeric member 4217) and/or the carrier assembly 4390(e.g., the proximal surface 4376 of the carrier body 4360).

As shown in FIGS. 27-29 , the gas vent assembly 4310 includes a first(or distal) member 4320, a second (or central) member 4330 and a third(or proximal) member 4340. These components are nested together suchthat the gas vent assembly 4310 can be transitioned from a collapsedconfiguration (FIG. 19 ) to an expanded configuration (FIG. 40 ), and aseries of partially expanded configurations therebetween. When the gasvent assembly 4310 is in the expanded configuration (FIG. 40 , afterdelivery of the medicament), the opening 4112, the O-ring 4113 and thepassageway 4346 collectively allow the gas to escape the medicamentcavity 4139, such that needle retraction can occur.

The first member 4320 includes a proximal end portion 4322 and a distalend portion 4321. The distal end portion 4321 includes a protrusion 4323configured to matingly engage the elastomeric member 4217. In thismanner, movement of the elastomeric member 4217 distally causes movementof first member 4320 distally. The proximal end portion 4322 includes apair of retention walls 4324 configured to engage a corresponding distalend surface 4333 of the second (or central) member 4330. Moreparticularly, the first member 4320 defines an opening within which thesecond member 4330 can slide. The retention walls 4324 limit movement ofthe second member 4330.

The second member 4330 includes a proximal end portion 4332 and a distalend portion 4331. The distal end portion 4331 includes the distal endsurface 4333 that engages the first member 4320. The second memberdefines an opening 4335 and a pair of side grooves 4336. The third (orproximal) member 4340 is movably disposed within the opening 4335. Inparticular, the distal protrusions 4343 of the third member 4340 slidewithin the side grooves 4336 and contact the proximal end portion 4332to limit movement of the third member 4340 within the second member4330.

The third member 4340 includes a proximal end portion 4342 and a distalend portion 4341. The distal end portion 4341 includes the distalprotrusions 4343 that engage the second member 4320. The proximal endportion 4342 includes a guide surface 4344 and a valve portion 4345. Theguide surface 4344 slides within the slots 4116 of the guide wall 4115.The valve portion 4345 defines a passageway 4346.

As shown in FIGS. 19, 30 and 31 , the safety lock 4700 includes a safetylock protrusion 4702 and an engagement portion 4720. As described above,when the safety lock 4700 is in a first (locked) position, the safetylock protrusion 4702 is configured to be disposed in the opening definedby the extensions 4553 of the release member 4550. Accordingly, thesafety lock protrusion 4702 is configured to prevent the extensions 4553from moving closer to each other, thereby preventing proximal movementof the release member 4550 and/or delivery of the medicament.

The engagement portion 4720 of the safety lock 4700 includes engagementmembers 4721 that extend in a proximal direction. The engagement members4721 have tabs 4722 that extend from a surface of the engagementmembers. The tabs 4722 engage the ribs 4236 of the sheath cover 4235 tolimit relative movement between the safety lock 4700 and the needlesheath assembly 4220, as described above. In this manner, the needlesheath assembly 4220 can protect the user from the needle 4216 and/orcan keep the needle 4216 sterile before the user actuates the medicalinjector 4000, and the needle sheath assembly 4220 can be removed fromabout the needle 4216 when the safety lock 4700 is removed.

The outer surface of the safety lock 4700 include a grip portion(lateral ribs) and indicia thereon. The grip portion provides an areafor the user to grip and/or remove the safety lock 4700 from about thehousing 4100. The indicia provide instruction on how to remove thesafety lock 4700. In some embodiments, for example, indicia can indicatethe direction the user should pull the safety lock 4700 to remove thesafety lock 4700.

FIGS. 32 and 33 show the base (or actuator) 4510 of the medical injector4000. The base 4510 includes a proximal (or inner) surface 4511, adistal (or outer) surface 4523 and base connection knobs 4518. Thedistal surface 4523 is disposed against a target surface (not shown)during use of the injector 4000. As described below, the housing 4100 ismoved distally relative to the base 4510 and/or the distal surface 4523,thereby causing the base 4510 to move proximally relative to the housing4100 to actuate the medical injector 4000. The base 4510 defines aneedle aperture 4513 and a safety lock protrusion aperture 4514. Theneedle aperture 4513 is configured to receive the needle 4216 when themedical injector 4000 is actuated. The safety lock protrusion aperture4514 of the base 4510 receives the safety lock protrusion 4702 of thesafety lock 4700 when the safety lock 4700 is coupled to the housing4100 and/or the base 4510.

The proximal surface 4511 of the base 4510 includes guide members (notshown) and protrusions 4515. The guide members of the base 4510 engageand/or slide within the base rail grooves 4114 of the housing 4100, asdescribed above. The protrusions 4515 of the base 4510 engage thetapered surfaces of the extensions 4553 of the release member 4550. Asdescribed in further detail herein, when the safety lock 4700 is removedand the base 4510 is moved in a proximal direction with respect to thehousing 4100, the protrusions 4515 of the base 4510 are configured tomove the extensions 4553 of the release member 4550 closer to eachother, actuating the medicament delivery mechanism 4300. As describedabove, the base connection knobs 4518 engage the base retention recesses4134 in a way that allows proximal movement of the base 4510 but limitsdistal movement of the base 4510.

The medical injector 4000 can be moved from the first configuration(FIGS. 18 and 19 ) to a second configuration (FIG. 34 ) by moving thesafety lock 4700 from a first position to a second position. The safetylock 4700 is moved from a first position to a second position by movingand/or removing the safety lock 4700 distally with respect to thehousing 4100. When the safety lock 4700 is moved from the first positionto the second position, the safety lock protrusion 4702 is removed frombetween the extensions 4553 of the release member 4550, thereby enablingthe medicament delivery mechanism 4300. As shown in FIG. 18 , prior toactuation, a portion of the medicament container assembly 4200 can beviewed via the status aperture 4130. Specifically, the container body4210 and the contents therein (e.g., the medicament) can be viewed. Asdescribed above, in some embodiments, the housing 4100 can include alabel or other indicia providing a color strip (against which themedicament can be compared), instructions for viewing or the like.Although not shown in FIG. 18 , in some embodiments, a portion of theelastomeric member 4217 is visible via the status aperture 4130.

After the safety lock 4700 is moved from the first position to thesecond position, the medical injector 4000 can be moved from the secondconfiguration (FIG. 34 ) to a third configuration (FIG. 35 ) by movingthe base 4510 from a first position to a second position. Similarlystated, the medical injector 4000 can be actuated by the system actuatorassembly 4500 by moving the base 4510 proximally relative to the housing4100. The base 4510 is moved from its first position to its secondposition by placing the medical injector 4000 against the body of thepatient and moving the base 4510 with respect to the housing 4100.Specifically, as described above the base includes a “contact portion”(i.e., the distal surface 4523) that can be placed against and/or incontact with the target location. Moving the base 4510 from the firstposition to the second position causes the base 4510 to engage theextensions 4553 of the release member 4550, thereby moving theextensions 4553 together. The inward movement of the extensions 4553causes engagement surface of the release member 4550 to becomedisengaged from the housing 4100, thereby allowing the release member4550 to be moved proximally along its longitudinal axis as the spring4576 expands.

When the base 4510 is moved from the first position to the secondposition, the system actuator assembly 4500 actuates the medicamentdelivery mechanism 4300, thereby placing the medical injector 4000 inits fourth configuration (i.e., the needle insertion configuration), asshown in FIGS. 36 and 37 . More particularly, when the medical injector4000 is in its fourth configuration, the puncturer 4575 of the releasemember 4550 is in contact with and/or disposed through the frangibleseal 4413 of the gas container 4410.

After the frangible seal 4413 has been punctured, an actuating portionof a compressed gas flows from the gas container 4410, via the gaspassageway and into the medicament cavity 4139. The gas applies gaspressure to flange 4214 of the medicament container and/or the topsurface of the carrier body 4360. Because the seals 4371, 4372 and theouter seal 4370 maintain the medicament cavity 4139 fluidically isolatedfrom the exterior of the device, the gas pressure exerts a force to movethe carrier assembly 4390 distally within the medicament cavity 4139, asshown in FIG. 37 . In this manner, the movement of the needle 4216 in adistal direction causes the distal end portion of the needle 4216 toexit the housing 4100 and enter the body of a patient prior toadministering the medicament.

As shown in FIG. 37 , when the device moves from the third configurationto the fourth configuration, the gas vent assembly expands from itscollapsed configuration (FIGS. 18, 34 ) to a partially expandedconfiguration. Notably, in the partially expanded configuration, thevalve portion 4345 is maintained in a sealed position within the opening4112 and the O-ring 4113. Thus, the medicament cavity 4139 is maintainedin fluidic isolation.

When the needle 4216 has extended by a desired distance, the distalsurface 4365 of the carrier body 4360 contacts the surface 4106 of thehousing 4100 to limit further distal movement of the carrier assembly4390 within the housing 4100. When the distal movement of the carrierassembly 4390 is prevented, the gas within the medicament cavity 4139(i.e., the gas chamber) continues to apply gas pressure to theelastomeric member 4217. This causes the elastomeric member 4217 (andtherefore the first member 4320 of the gas vent assembly 4310) to movein the distal direction with the medicament container body 4210. Distalmovement of the elastomeric member 4217 generates a pressure upon themedicament contained within the medicament container assembly 4200,thereby allowing at least a portion of the medicament to flow out of themedicament container 4200 via the needle 4216. The medicament isdelivered to a body of a user via the medicament delivery path definedby the medicament container 4200 and the needle 4216. At the end ofinjection, the medical injector is in its fifth configuration (FIG. 40).

As shown in FIG. 39 , when the medical injector 4000 is in its fifthconfiguration, a portion of the medicament container assembly 4200, aportion of the carrier body 4360, and a portion of the gas vent assembly4310 can be viewed via the status aperture 4130. As described above, insome embodiments, the housing 4100 can include a label or other indiciaproviding a color strip to assist the user in identifying the carrier,providing instructions for viewing, or the like. Although not shown inFIG. 18 , in some embodiments, a portion of the elastomeric member 4217is visible via the status aperture 4130 when the medical injector 4000is in its fifth configuration.

As shown in FIGS. 40 and 41 , as the elastomeric member 4217 movesdistally, the gas vent assembly 4310 continues to move to its fullyexpanded configuration. After the elastomeric member 4217 has moved apredetermined distance within the medicament container body 4210(corresponding to the desired dose), the valve portion 4345 is movedfrom within the opening 4112 thereby allowing the pressurized gascontained within the gas chamber (i.e., the volume within the medicamentcavity 4139 between the proximal end of the housing 4100 and the surfaceof the carrier 4360) to escape via the passageway 4346 and the opening4112. After the gas pressure within the medicament cavity 4139 decreasesbelow a certain level, the force exerted by the retraction spring 4380on the carrier body 4360 is sufficient to cause the carrier body 4360 tomove proximally within the housing 4100 (i.e., to retract). This placesthe medical injector in its sixth configuration (FIGS. 42 and 43 ).

As shown in FIG. 42 , when the medical injector 4000 is in its sixthconfiguration, a portion of the medicament container assembly 4200 canbe viewed via the status aperture 4130. Specifically, as shown, thecontainer body 4210 and a portion of the elastomeric member 4217 arevisible via the status aperture 4130. As described above, in someembodiments, the housing 4100 can include a label or other indiciaproviding a color strip to assist the user in identifying theelastomeric member, providing instructions for viewing, or the like.Although not shown in FIG. 18 , in some embodiments, a portion of thecarrier 4360 is visible via the status aperture 4130 when the medicalinjector 4000 is in its sixth configuration.

As described above, the medicament delivery mechanism 4300 is consideredto be a “pistonless” system. With a pistonless gas-poweredauto-injector, the force exerted by the gas can move the medicamentcontainer relative to the housing and similarly, can move theelastomeric member 4217 relative to (e.g., within) the container body4210. In some embodiments, by not including a movable mechanism, apiston, and/or the like, a height of the medical injector 4000 can bereduced relative to, for example, the height of a device that includes arigid, single length piston.

In some embodiments, any of the devices shown and described herein caninclude an electronic circuit system to provide user instruction and/orfeedback. In some embodiments the electronic circuit system can beintegral to the device (e.g., included within the housing, such as thehousing 4100). In other embodiments, the electronic circuit system canbe an external, discrete component that is affixed to the device. Forexample, FIG. 44 shows a photograph of a medical injector 5000′ thatincludes an electronic circuit system 5900′.

The medical injector 5000′ includes a housing 5100′, a system actuationassembly (not shown), a medicament container assembly (not shown), amedicament delivery mechanism (not shown), a base', a safety lock 5700′,and an electronic circuit system 5900′. Although not shown in FIG. 44 ,the system actuation assembly is similar to the system actuationassembly 4500 described above with respect to the medical injector 4000(see FIGS. 16-17 ). Thus, the system actuation assembly of the medicalinjector 5000′ is not described in detail herein. Although not shown inFIG. 44 , the medicament container assembly is similar to the medicamentcontainer assembly 4200 described above with respect to the medicalinjector 4000 (see FIG. 26 ). Thus, the medicament container assembly ofthe medical injector 5000′ is not described in detail herein. Althoughnot shown in FIG. 44 , the medicament delivery mechanism is similar tothe medicament delivery mechanism 4300 described above with respect tothe medical injector 4000 (see FIGS. 22-29 ). Thus, the medicamentdelivery mechanism of the medical injector 5000′ is not described indetail herein.

As shown, the housing 5100′ has a proximal end portion 5101′ and adistal end portion 5102′. The housing 5100′ defines a first statusindicator aperture 5130′ (on the first or front side) and a secondstatus indicator aperture (not shown, on the second or back side). Thestatus indicator aperture 5130′ can allow a patient to monitor thestatus and/or contents of the medicament container, the carrier, and themedicament contained within the housing 5100. For example, by visuallyinspecting the status indicator apertures 5130′, a patient can determinewhether the medicament container contains a medicament and/or whetherthe medicament has been dispensed.

As shown, the housing 5100′ includes a label 5165′ that includes aseries of indicia 5166′. The indicia 5166′ include the colored portionsthat mask or otherwise accentuate the status indicator aperture 5130′and/or the contents viewed therethrough. The indicia 5166′ also includeinstructions for use, descriptions of the device 5000′, and the like.The label 5165′ also defines an opening through which the soundapertures 5173′ can be exposed.

The medical injector 5000′ includes an electronic circuit systemconfigured to control, actuate, and/or otherwise produce an outputassociated with a portion of the medical injector 5000′. Although notshown in FIG. 44 , the safety lock 5700′ includes a battery isolationtab, which functions similar to a battery isolation protrusion of thecover, described in detail in the '849 patent. In particular, the safetylock 5700′ can include a protrusion that extends into the housing 5100′and selectively isolates a power source (e.g., a battery) from theremaining portions of the electronic circuit system 5900′. Thus, removalof the safety lock 5700′ results in (1) removal of a needle sheath(similar to the sheath assembly 4220 described above), and (2)electrically connecting a battery to a remainder of an electroniccircuit system, thus producing an initial electronic output. In someembodiments, the removal of the safety lock can also engage a switch toproduce an electronic output instructing a user in the operation of themedical injector 5000′. Specifically, in some embodiments, the safetylock 5700′ includes a protrusion that engages a circuit board orotherwise contacts a switch or sensor (not shown) to produce anelectronic output. The electronic circuit system of the medical injector5000′ can be similar to any of the electronic circuit systems shown anddescribed herein and in the '849 patent.

In some embodiments, the electronic circuit system 5900′ (and any of theelectronic circuit systems described herein) can include an audio outputdevice configured to output audible sound to a user in response to useof the medical injector 5000′. In some embodiments, the audible outputdevice can be a speaker. In some embodiments, the audible sound can be,for example, associated with a recorded message and/or a recordedspeech. In other embodiments, the audible instructions can be an audiblebeep, a series of tones and/or or the like.

In some embodiments, the electronic circuit system 5900′ (and any of theelectronic circuit systems described herein) can include a light outputdevice configured to output a visual signal to a user in response to useof the medical injector 5000′. In some embodiments, the light outputdevice can be a light emitting diode (LED). In some embodiments, thevisual signal can be, for example, a series of flashes, a sequence oflights, or the like.

In some embodiments, the electronic circuit system 5900′ (and any of theelectronic circuit systems described herein) can include a networkinterface device (not shown) configured to operatively connect theelectronic circuit system 5900′ to a remote device (not shown) and/or acommunications network (not shown). In this manner, the electroniccircuit system 5900′ can send information to and/or receive informationfrom the remote device. The remote device can be, for example, a remotecommunications network, a computer, a compliance monitoring device, acell phone, a personal digital assistant (PDA) or the like. Such anarrangement can be used, for example, to download replacementprocessor-readable code from a central network to the electronic circuitsystem 5900′. In some embodiments, for example, the electronic circuitsystem 5900′ can download information associated with a medical injector5000′, such as an expiration date, a recall notice, updated useinstructions or the like. Similarly, in some embodiments, the electroniccircuit system 5900, can upload information associated with the use ofthe medical injector 5000′ via the network interface device (e.g.,compliance information or the like).

In addition to providing user instruction and/or feedback via theelectronic circuit system, the medical injector 5000′ can also provideuser feedback and/or instruction via a visual status window 5130′. Thestatus window 5130′ and/or a portion of the housing are configured suchthat various portions of the medicament delivery mechanism and/or themedicament container are visible therethrough during various stages ofoperation. For example, in some embodiments, all or portions of amedicament container assembly and/or movable mechanism (e.g., aprefilled syringe, an elastomeric member or plunger, a carrier, amovable mechanism, etc., as shown and described in the '849 patent) canbe visible through the status window 5130′.

In some embodiments, the medical injector 5000′ can providenon-electronic user feedback and/or instruction via a sound produced bythe pressurized gas, by the interface between components duringactuation, or the like. In this manner, the medical injector 5000′ caninclude both electronic outputs (e.g., via lights and/or sound) andnon-electronic outputs (e.g., via the status window and/or an acousticnoise output). In some embodiments, for example, the gas release valve(similar to the gas relief opening 4112 and the gas venting assembly4310 described above) can include an orifice or chamber such that theescaping gas produces a sound or “whistle.” In some embodiments, theorifice or flow path can be configured such that the sound is within adesired frequency range or loudness. In other embodiments, thenon-electronic output can be a clicking sound, a snapping sound, aclapping sound, a cracking sound, and/or any other suitable audibleoutput. In other embodiments, the base can produce a distinct snappingsound when it contacts a locking feature of the housing duringactuation. In yet other embodiments, one or more prefilled syringeswithin the medical injector 5000′ can be disposed within a carrierinside of the housing (not shown in FIG. 1 ). The carrier can produce adesired sound when it impacts an internal surface of the housing duringactuation. In other embodiments, a component inside the housing canproduce an audible output only after the needle is inserted into thepatient, only after the drug is delivered into the patient, or onlyafter the needle retracts into the housing. This output may be differentthen the activation sound or output.

FIGS. 45-48 are perspective views of a medical injector 5000 thatincludes an electronic circuit system 5900. The medical injector 5000includes a housing 5100, a system actuation assembly (not shown), amedicament container assembly (not shown), a medicament deliverymechanism (not shown), a base', a safety lock 5700. Although not shown,the system actuation assembly is similar to the system actuationassembly 4500 described above with respect to the medical injector 4000(see FIGS. 16-17 ). Thus, the system actuation assembly of the medicalinjector 5000 is not described in detail herein. Although not shown, themedicament container assembly is similar to the medicament containerassembly 4200 described above with respect to the medical injector 4000(see FIG. 26 ). Thus, the medicament container assembly of the medicalinjector 5000 is not described in detail herein. Although not shown, themedicament delivery mechanism is similar to the medicament deliverymechanism 4300 described above with respect to the medical injector 4000(see FIGS. 22-29 ). Thus, the medicament delivery mechanism of themedical injector 5000 is not described in detail herein. The electroniccircuit system 5900 of the medical injector 5000 is similar to that ofthe medical injector 5000′ and is therefore not described in detail.

Although the medical injector 5000′ and the medical injector 5000 areshown as being devoid of an outer cover, in other embodiments, themedical injector 5000′, the medical injector 5000, and any of themedicament delivery devices shown and described herein can include anouter cover that covers and/or surrounds at least a portion of thehousing, the safety lock and/or the base. Such covers can also cover thestatus apertures to limit the light that is transmitted into themedicament container. Such covers can also interact with an electroniccircuit system (e.g., the electronic circuit systems 5900′ and 5900),causing the production of an electronic output when the cover and/or asafety lock is removed.

For example, FIGS. 49-50 show an example of a cover 5190 that can beused with and/or included in the medical injector 5000 or any of themedicament delivery devices described herein. The cover 5190 includes aproximal end portion 5191 and a distal end portion 5192, and defines acavity 5196. The cavity 5196 of the cover 5190 is configured to receiveat least a portion of the housing 5100. Thus, when the portion of thehousing 5100 is disposed within the cover 5190, the cover 5190 blocks anoptical pathway between the medicament container and a region outside ofthe housing 5100. Similarly stated, when the portion of the housing 5100is disposed within the cover 5190, the cover 5190 obstructs the firststatus indicator aperture 5130 to reduce the amount of light transmittedto the medicament. In this manner, the life of the medicament can beextended by the prevention and/or reduction of degradation to themedicament that may be caused by ultra-violet radiation. In otherembodiments, however, such those containing a medicament that is notsensitive to ultraviolet (UV) radiation, the cover 5190 can includeviewing windows and/or openings that substantially correspond to theaperture 5130.

The proximal end portion 5191 of the cover 5190 defines apertures 5193configured to receive the retention protrusions (not shown) of thehousing 5100. In this manner, the apertures 5193 and the retentionprotrusions of the housing 5100 removably retain the cover 5190 about atleast a portion of the housing 5100.

As described above, the electronic circuit system 5900 can be actuatedwhen the housing 5100 is at least partially removed from the cover 5190.More particularly, the distal end portion 5192 of the cover 5190includes the battery isolation protrusion 5197. The battery isolationprotrusion 5197 includes a proximal end portion 5236 and a taperedportion 5237. The proximal end portion 5236 of the battery isolationprotrusion 5197 is configured to be removably disposed between a portionof a power source.

While the medical injectors 5000′ and 5000 are shown as having thestatus windows (e.g., window 5130′) disposed substantially at or near alatitudinal center of the medical injectors 5000′ and 5000, in otherembodiments, a medical injector can be configured to include amedicament container such as a prefilled syringe or the like disposedoff-centered or otherwise in a non-coaxial arrangement with an energystorage member. For example, the medical injector 4000 includes themedicament container assembly 4200 that is disposed in a substantiallyoff-center position relative to a width of the medical injector 4000. Inother words, the medicament container is non-coaxial with the energystorage member. Moreover, because the medicament container is off-centerrelative to the width of the medical injector 4000, the status aperture4130 defined by the housing is similarly off-center relative to thewidth of the medical injector 4000.

In some embodiments, a medicament delivery device can include two ormore medicament containers, each having a delivery member through whichthe medicament therein can be delivered. Such embodiments canaccommodate the delivery of viscous medicaments and/or large volumes ofmedicament (e.g. >1 mL dose) by delivering portions of the overall dosein parallel. Specifically, as discussed above with respect to Eq. 1, theneedle length (L) and the needle gauge (identified as the radius R ofthe needle lumen) can have a profound impact on the pressure needed todeliver a desired volume of medicament therethrough. Thus, by using a“parallel delivery” device of the types shown and described herein,delivery of viscous medicaments, such as certain large or macromolecularinjectables that include carbohydrate-derived formulations, lipids,nucleic acids, proteins/peptides (e.g. monoclonal antibodies) and otherbiotechnologically-derived medicaments, can be facilitated.

For example, FIGS. 51-54 show schematic illustrations of a “dualcontainer” device 6000 according to an embodiment in a first, second,third and fourth configuration, respectively. The medicament deliverydevice 6000 includes a housing 6100, two medicament containers 6200A and6200B, an energy storage member 6400, and a retraction member 6351. Thehousing 6100 defines a gas chamber 6139 that receives a pressurized gasfrom the energy storage member 6400. The gas chamber 6139 can be of anysuitable size and shape, and can be, for example, a portion of thevolume defined by the housing 6100 within which a portion of the firstmedicament container 6200A and/or the second medicament container 6200Bare disposed. Although not shown, in some embodiments, the housingincludes a vent mechanism, such as an opening or valve, of the typesshown and described herein (e.g., with respect to the device 1000 andthe device 4000). In this manner, the gas pressure within the gaschamber 6139 can be reduced upon completion of the injection event.

The housing 6100 can be any suitable size, shape, or configuration andcan be made of any suitable material. For example, in some embodiments,the housing 6100 is an assembly of multiple parts formed from a plasticmaterial and defines a substantially rectangular shape when assembled.In other embodiments, the housing 6100 can have a substantiallycylindrical shape.

The medicament containers 6200A, 6200B each have a container body thatdefines a volume that contains (i.e., is filled with or partially filledwith) a medicament. The distal end portion of each medicament container6200A, 6200B is coupled to a needle 6216A, 6216B, respectively, throughwhich the medicament can be delivered. In some embodiments, themedicament container 6200A and the medicament container 6200B can eachbe a prefilled syringe having the needle 6216A, 6216B, respectively,staked thereto. Such prefilled syringes can be any of the types shownand described herein.

The medicament container 6200A and the medicament container 6200B eachinclude an elastomeric member 1217A, 1217B, respectively, that seals themedicament within the container body. The elastomeric members 1217A,1217B are configured to move within the container body to inject themedicament from the medicament container assembly 1200. The elastomericmembers 1217A, 1217B can be of any design or formulation suitable forcontact with the medicament, of the types shown and described herein.

Although the medicament container 6200A and the medicament container6200B are shown as being parallel to and noncoaxial with each other, inother embodiments, the medicament container 6200A and the medicamentcontainer 6200B can be arranged in any suitable manner within thehousing 6100. Moreover, although the medicament container 6200A and themedicament container 6200B are shown as being disposed within thehousing 6100 without a carrier, in other embodiments, the medicamentcontainer 6200A and the medicament container 6200B can each be disposedwithin a carrier (or set of carriers) to facilitate movement within thehousing 6100.

The energy storage member 6400 is disposed within the housing 6100, andis configured to convey a pressurized gas into the gas chamber 6139produce a force F₁ (see FIGS. 51-53 ) to convey the contents of the twomedicament containers 6200A and 6200B when the energy storage member6400 is actuated. The energy storage member 6400 can be any suitablemember or device that stores potential energy and, when actuated,produces the pressurized gas. For example, the energy storage member6400 (and any of the energy storage members described herein) can be anyof a device containing compressed gas, a device containing a vaporpressure-based propellant or the like.

Thus, when actuated the energy storage member 6400 produces a force F₁to deliver the medicament contained within the medicament containers6200A, 6200B. More specifically, the energy storage member 6400 producesthe force F₁ that moves the medicament containers 6200A, 6200B from afirst position to a second position in a first direction indicated bythe arrow AA in FIG. 52 and/or that moves the plungers 6217A, 6217B froma first plunger position to a second plunger position as shown by thearrows BB in FIG. 53 . By employing the energy storage member 6400 toproduce the force F₁ rather than relying on a user to manually producethe delivery force, the medicament can be delivered into the body at thedesired pressure and/or flow rate, and with the desired deliverycharacteristics. Moreover, this arrangement reduces the likelihood ofpartial delivery (e.g., that may result if the user is interrupted orotherwise rendered unable to manually produce the force to complete thedelivery). Moreover, by including a single energy storage member 6400, auser can initiate delivery from both medicament containers via a singleactuation operation.

In some embodiments, the energy storage member 6400 can be configurableto include various amounts of stored energy without changing the size ofthe energy storage member. In such embodiments, therefore, a high force(e.g., to inject viscous medicaments) can be achieved in the samepackaging that is used for lower viscosity medicaments. For example, insome embodiments, the energy storage member 6400 can be a compressed gascylinder having any desired pressure (and thus, mass) of gas therein.Accordingly, the pressure and/or force (e.g., force F₁) can be achievedto complete the operations described herein, regardless of themedicament.

As shown, the energy storage member 6400 is operably coupled (e.g., viathe gas chamber 6139) to the medicament containers 6200A, 6200B and/orthe medicament therein such that the force F₁ delivers the medicament.In some embodiments, for example, the force F₁ can be transmitted to themedicament containers and/or the medicament therein via a carrier ormovable member (not shown). When the medicament delivery device 6000 isactuated to produce the force F₁, the medicament containers 6200A, 6200Bmove from the first position (see FIG. 51 , which corresponds to thefirst configuration of the medicament delivery device 6000) to thesecond position (see FIG. 52 , which corresponds to the secondconfiguration of the medicament delivery device 6000). As shown, themovement of the medicament containers 6200A, 6200B within the housing6100 results in a needle insertion operation.

When the medicament containers 6200A, 6200B are in their respectivesecond positions, the pressure within the gas chamber 6139 continues toexert a force on the elastomeric members 6217A, 6217B. This causes eachelastomeric member 6217A, 6217B to move within its respective containerbody to expel the medicament therefrom, as shown by the arrows BB inFIG. 53 . The movement of the elastomeric member 6217A, 6217B places themedicament delivery device 6000 in a third configuration.

Although shown as moving substantially simultaneously, in otherembodiments, the medicament container 6200A and the medicament container6200B can move within the housing 6100 at different times. Further, inother embodiments, the elastomeric member 6217A and the elastomericmember 6217B can move within their respective container bodies atdifferent times. In some embodiments, the medicament delivery device6000 includes a gas vent assembly, such as the gas vent assembly 4310,to release the pressure within the gas chamber 6139 as a function of theposition of the elastomeric member 6217A and/or the elastomeric member6217B.

After the medicament is delivered, the retraction member 6351 exerts aretraction force F₂ on the medicament container 6200A and the medicamentcontainer 6200B. The force F₂ is applied in a second direction, oppositethe first direction. The retraction force F₂ moves the medicamentcontainers from the second position (e.g., the second and thirdconfiguration, as shown in FIGS. 52 and 53 ) in the direction of thearrow CC toward the first position, as shown in FIG. 54 . In thismanner, the retraction member 6351 produces the retraction force F₂ andmoves the medicament containers 6200A, 6200B (and their respectiveneedles) away from the body of the patient and into the housing 6100 ofthe medicament delivery device 6000.

The retraction member 6351 can be any suitable device or mechanism that,when actuated, produces a force F₂ to move the medicament containers inthe second direction as indicated by the arrow CC in FIG. 54 . In someembodiments, the retraction member 6351 can be a mechanical energystorage member, such as a spring, a device containing compressed gas, adevice containing a vapor pressure-based propellant or the like. Inother embodiments, the retraction member 6351 can be an electricalenergy storage member, such as a battery, a capacitor, a magnetic energystorage member or the like. In yet other embodiments, the retractionmember 6351 can be a chemical energy storage member, such as a containercontaining two substances that, when mixed, react to produce energy.Although the retraction member 6351 is shown as being separate anddistinct from the energy storage member 6400, in some embodiments, theenergy storage member 6400 can be configured to produce the retractionforce F₂.

FIGS. 55-58 show schematic illustrations of a “dual container” device7000 according to an embodiment in a first, second, third and fourthconfiguration, respectively. The medicament delivery device 7000includes a housing 7100, two medicament containers 7200A and 7200B, twomovable members 7300A and 7300B, an energy storage member 7400, and aretraction member 7351. The housing 7100 can be any suitable size,shape, or configuration and can be made of any suitable material. Forexample, in some embodiments, the housing 7100 is an assembly ofmultiple parts formed from a plastic material and defines asubstantially rectangular shape when assembled. The housing 7100 candefine any suitable status apertures (or windows) as shown herein.

The medicament containers 7200A, 7200B are disposed within the housing7100, and contains (i.e., is filled or partially filled with) amedicament of the types described herein. For example, each medicamentcontainer 7200A, 7200B can be a prefilled syringe of the types describedherein, and can include a proximal end portion having a flange (6214A,7214B), and a distal end portion that is coupled to a needle (not shownin FIGS. 55-58 ). Each medicament container 7200 includes an elastomericmember 7217A, 7217B (also referred to herein as a “plunger”).

The energy storage member 7400 can be any suitable device or mechanismthat, when actuated, produces a force F₁ to deliver the medicamentcontained within the medicament containers 7200A, 7200B. Similarlystated, the energy storage member 7400 can be any suitable device ormechanism that produces the force F₁ such that the medicament isconveyed from the medicament containers into a body of a patient. Morespecifically, the energy storage member 7400 produces the force F₁ thatmoves the medicament containers 7200A, 7200B from a first position to asecond position in a first direction indicated by the arrow AA in FIG.55 and/or that moves the plungers 7217A, 7217B from a first plungerposition to a second plunger position as shown by the arrows BB in FIG.56 . By employing the energy storage member 7400 to produce the force F₁rather than relying on a user to manually produce the delivery force,the medicament can be delivered into the body at the desired pressureand/or flow rate, and with the desired delivery characteristics.Moreover, this arrangement reduces the likelihood of partial delivery(e.g., that may result if the user is interrupted or otherwise renderedunable to manually produce the force to complete the delivery).

In some embodiments, the energy storage member 7400 can be a mechanicalenergy storage member, such as a spring, a device containing compressedgas, a device containing a vapor pressure-based propellant or the like.In other embodiments, the energy storage member 7400 can be anelectrical energy storage member, such as a battery, a capacitor, amagnetic energy storage member or the like. In yet other embodiments,the energy storage member 7400 can be a chemical energy storage member,such as a container containing two substances that, when mixed, react toproduce energy.

In some embodiments, the energy storage member 7400 can be configurableto include various amounts of stored energy without changing the size ofthe energy storage member. In such embodiments, therefore, a high force(e.g., to inject viscous medicaments) can be achieved in the samepackaging that is used for lower viscosity medicaments. For example, insome embodiments, the energy storage member 7400 can be a compressed gascylinder having any desired pressure (and thus, mass) of gas therein.Accordingly, the pressure and/or force (e.g., force F₁) can be achievedto complete the operations described herein, regardless of themedicament.

As shown in FIG. 55 , the energy storage member 7400 is operably coupledto the movable members 7300A, 7300B, the medicament containers 7200A,7200B and/or the medicament therein such that the force F₁ delivers themedicament. In some embodiments, for example, the force F₁ can betransmitted to the medicament containers and/or the medicament thereinvia the movable members. The movable members 7300A, 7300B can be anysuitable member, device, assembly or mechanism configured to move withinthe housing 7100. As shown in FIGS. 55-58 , the movable members 7300A,7300B include a piston portion configured to transmit the force F₁ tothe plungers 7217A, 7217B disposed within each medicament container.

As shown, when the medicament delivery device 7000 is actuated toproduce the force Fi, the movable members 7300A, 7300B move themedicament containers 7200A, 7200B from the first position (see FIG. 55, which corresponds to the first configuration of the medicamentdelivery device 7000) to the second position (see FIG. 56 , whichcorresponds to the second configuration of the medicament deliverydevice 7000). In some embodiments, the movement of the medicamentcontainers within the housing 7100 results in a needle insertionoperation.

In some embodiments, a shoulder of each movable member 7300A, 7300B canbe configured to maintain a distance between the piston portion of themovable member and the plunger when the medicament delivery device 7000is in the first configuration (FIG. 55 ). Similarly stated, in someembodiments, each movable member and its respective medicament containerare collectively configured such that the piston portion is spaced apartfrom the respective plunger when the medicament delivery device 7000 isin its storage configuration and/or when the medicament containers7200A, 7200B are moving between its first position and its secondposition. In this manner, any preload or residual force produced by theenergy storage member 7400 on the movable members 7300A, 7300B is nottransferred to the plungers 7217A, 7217B.

As shown in FIGS. 55-58 , each movable member 7300A, 7300B includes adeformable portion 7338A, 7338B configured to deform when the medicamentcontainer 7200 is in the second position such that at least a portion ofthe force F₁ is exerted upon the plungers 7217A, 7217B. In someembodiments, the deformable portions 7338A, 7338B can be separated fromthe movable member 7300A, 7300B. In this manner, the piston portion ofeach movable member 7300A, 7300B transmits at least a portion of theforce F₁ to is respective plunger 7217A, 7217B, thereby placing themedicament container 7200 into the third configuration (FIG. 57 ). Morespecifically, when the deformable portions 7338A, 7338B deform, thepiston portions each move within the respective medicament container inthe direction of the arrow BB (FIG. 57 ) and moves each plunger withinthe medicament container to deliver the medicament contained therein.

After the medicament is delivered, the retraction member 7351 exerts aretraction force F₂ on each movable member 7300A, 7300B in a seconddirection, opposite the first direction. When the retraction force F₂ isexerted, a second shoulder of each movable member 7300A, 7300B engages adistal surface of each flange 7214A, 7214B, thereby exerting at least aportion of the retraction force F₂ thereon. The exertion of theretraction force F₂ on the flanges 7214A, 7214B moves the medicamentcontainers from the second position (e.g., the second and thirdconfiguration, as shown in FIGS. 56 and 57 ) in the direction of thearrow CC toward the first position, as shown in FIG. 58 . In thismanner, the retraction member 7351 produces the retraction force F₂ andmoves the medicament container 7200 (and a needle) away from the body ofthe patient and into the housing 7100 of the medicament delivery device7000.

The retraction member 7351 can be any suitable device or mechanism that,when actuated, produces a force F₂ to move the medicament containers inthe second direction as indicated by the arrow CC in FIG. 58 . In someembodiments, the retraction member 7351 can be a mechanical energystorage member, such as a spring, a device containing compressed gas, adevice containing a vapor pressure-based propellant or the like. Inother embodiments, the retraction member 7351 can be an electricalenergy storage member, such as a battery, a capacitor, a magnetic energystorage member or the like. In yet other embodiments, the retractionmember 7351 can be a chemical energy storage member, such as a containercontaining two substances that, when mixed, react to produce energy.Although the retraction member 7351 is shown as being separate anddistinct from the energy storage member 7400, in some embodiments, theenergy storage member 7400 can be configured to produce the retractionforce F₂.

Although shown as including two distinct movable members 7300A, 7300B,in other embodiments, a dual container medical injector can include asingle structure or movable member that acts upon both medicamentcontainers.

In some embodiments, a medical injector can include two prefilledsyringes, each containing up to 1 mL of medicament (or more), and eachhaving a needle. Upon actuation of the device (as described above), asingle energy storage member (e.g., a compressed gas container) canrelease energy to move the two containers within the housing insubstantially the same operation to inject the two needles. The forceproduced by the energy storage member can further inject the medicamentfrom each container. In some embodiments, a single retraction member(e.g., a spring) can retract the two medicament containers therebywithdrawing the two needles into the housing. In other embodiments, adevice can include separate retraction members associated with eachmedicament container.

FIGS. 59-78 show a dual-container medical injector 8000 (also referredto as “auto-injector,” “injector,” or “device”), according to anembodiment. The medical injector 8000 is a gas-powered auto-injectorconfigured to deliver a medicament contained within two prefilledsyringe assemblies 4200, as described herein. The medical injector 8000includes a housing 8100 (see e.g., FIGS. 62-63 ), a system actuationassembly 8500 (see e.g., FIG. 65 ), two medicament container assemblies4200, a medicament delivery mechanism 8300 (see e.g., FIG. 70 ), a base8510 (or actuator, see FIG. 73 ); and a safety lock 8700 (see FIGS.71-72 ). As shown in FIGS. 62-63 , the housing 8100 has a proximal endportion 8101 and a distal end portion 8102. The operation of, andcertain components within, the medical injector 8000 are similar in manyrespects to that of the medical injector 4000, and thus certain aspectsare not described in detail herein. For example, as described herein,the medicament container assembly within the medical injector 8000 isthe same as the medicament container assembly 4200 shown and describedabove. One way that the medical injector 8000 differs from the medicalinjector 4000 is that the dual-container medical injector includes a gasvent mechanism that actuates a single release valve, as discussed inmore detail below.

The housing 8100 defines a pair of front status indicator apertures8130A, 8130B and a pair of rear status indicator apertures 8160A, 8160B.The front status indicator apertures 8130A, 8130B are defined by thehousing 8100 and are located on a first side of the housing 8100, andthe rear status indicator apertures 8160A, 8160B are located on a secondside of the housing 8100. The status indicator apertures 8130A, 8160Acan allow a patient to monitor the status and/or contents of the firstmedicament container assembly 4200, the first carrier 4360, and themedicament contained therein. The status indicator apertures 8130B,8160B can allow a patient to monitor the status and/or contents of thesecond medicament container assembly 4200, the second carrier 4360, andthe medicament contained therein.

In some embodiments, the housing 8100 can include a label or indiciathat mask or otherwise accentuates the status indicator apertures 8130A,8130B, 8160A, 8160B and/or the contents viewed therethrough. Forexample, in some embodiments, the housing 8100 can include a label (notshown) having border that surrounds at least a portion of the statusindicator apertures. In some embodiments, a label can include indicatorcolors that alert user (or assist a user in determining) whether themedicament is properly colored, whether a portion of the carrier 8360A,8360B is visible through the window or the like.

As shown in FIGS. 62 and 63 , the housing 8100 defines a gas containercavity 8151 and a first medicament cavity 8139A, and a second medicamentcavity 8139B. The gas container cavity 8151 is configured to receive thegas container 8410 and a portion of the system actuator assembly 8500(e.g., a release member 8550 and the spring 8576, as shown in FIG. 65 ).The proximal end portion 8152 of the gas container cavity 8151 isconfigured to receive the gas container retention member 8580 of aproximal cap 8103 of the housing 8100, as described in further detailherein. The gas container cavity 8151 is in fluid communication with thefirst medicament cavity 8139A and the second medicament cavity 8139B viagas passageways (not shown).

The first medicament cavity 8139A is configured to receive the firstmedicament container assembly 4200 and at least a portion of themedicament delivery mechanism 8300. In particular, as described below,the medicament delivery mechanism 8300 includes a first carrier assembly4390 and a gas vent assembly 8310 movably disposed in the housing 8100.The first medicament cavity 8139A is in fluid communication with aregion outside the housing 8100 via a first needle aperture 8105A (seee.g., FIG. 63 ) and also the vent opening 8112.

The second medicament cavity 8139B is configured to receive the secondmedicament container assembly 4200 and at least a portion of themedicament delivery mechanism 8300. The second medicament cavity 8139Bis in fluid communication with a region outside the housing 8100 via asecond needle aperture 8105B (see e.g., FIG. 63 ) and also the ventopening 8112.

The proximal end portion 8101 of the housing 8100 includes a proximalcap 8110 (see e.g., FIGS. 64 and 68 ). The proximal cap 8110 includes agas container retention member 8180 and defines a gas passageway betweenthe medicament cavities 8139A, 8139B and the gas container cavity 8151.The gas container retention member 8180 is configured to receive and/orretain a gas container 8410 that contains a pressurized gas, as shown inFIG. 65 . When the medical injector 8000 is actuated, pressurized gasfrom the gas container 8410 is conveyed from the gas container cavity8151 to the medicament cavities 8139A, 8139B via the gas passageways.Said another way, the gas passageways place the gas container cavity8151 in fluid communication with the medicament cavities 8139A, 8139B.Thus, the proximal portion of the medicament cavity 8139A and themedicament cavity 8139B can be referred to as a gas chamber.

As shown in FIG. 67 , the proximal cap 8110 also includes an O-ring 8113and defines the vent opening 8112. As described herein, the vent opening8112 provides the passageway through which pressurized gas is conveyedfrom the medicament cavity 8139A (or gas chamber portion of themedicament cavity 8139A) and the medicament cavity 8139B (or gas chamberportion of the medicament cavity 8139B) to a volume outside of themedical injector 8000. In this manner, the force produced by thepressurized gas on the medicament delivery mechanism 8300 and/or themedicament container assemblies 4200 can be reduced to allow needleretraction after the injection is completed. As shown in FIG. 68 , theO-ring 8113, in conjunction with the valve portion 8345 of the gas ventassembly 8310, selectively seals the vent opening 8112 during needleinsertion and delivery of the medicament.

The proximal cap 8110 includes a guide walls 8115A, 8115B within whichthe first (or proximal) member 8340 of the gas vent assembly 8310 moves.The guide walls 8115A, 8115B also each include an end surface 8117 (seeFIG. 64 ) against which a flange 4214 of the container body 4210 restswhen the medical injector 8000 is in its first configuration (i.e., the“storage” state).

As shown in FIG. 63 , the distal end portion 8102 of the housing 8100includes a first shoulder 8106A and a second shoulder 8106B and definesa first needle aperture 8105A and a second needle aperture 8105B. Thedistal end portion 8102 also includes base rail grooves 8114 and baseretention recesses 8134 (see FIG. 62 ). The shoulders 8106A, 8106B areeach configured to contact a corresponding surface 4365 of the carrierbody 4360 (see e.g., FIG. 68 ) when the needle 4216 from each respectivemedicament container assembly 4200 has been inserted a desired distance.In this manner the shoulders 8106A, 8106B can act as an “end stop” orinsertion limiting mechanism. The needle apertures 8105A, 8105B are theopenings through which each needle 4216 is disposed when the medicalinjector 8000 is actuated, as described in further detail herein.

The distal end portion 8102 of the housing also includes a releasemember contact surface 8126, and defines the release member aperture. Asshown in FIG. 67 , the release member aperture 8145 receives a distalend portion 5152 of a release member 8550, such that the extensions 8553of the release member 8550 engage with the release member contactsurface to prevent activation of the medical injector 8000. The safetylock 8700, its components and functions are described in more detailbelow, and similar to the function of the safety lock 4700 describedabove.

The distal base retention recesses 8134 are configured to receive thebase connection knobs 8518 of the actuator 8510 (also referred to hereinas “base 8510,” see e.g., FIG. 72 ) when the base 8510 is in a firstposition relative to the housing 8100. The proximal-most pair of baseretention recesses 8134 are configured to receive the base connectionknobs 8518 of the base 8510 when the base 8510 is in a second (i.e.,actuated) position relative to the housing 8100. The base retentionrecesses 8134 have a tapered proximal sidewall and a non-tapered distalsidewall. This allows the base retention recesses 8134 to receive thebase connection knobs 8518 such that the base 8510 can move proximallyrelative to the housing 8100, but cannot move distally relative to thehousing 8100. Said another way, the distal-most set of base retentionrecesses 8134 are configured to prevent the base 8510 from movingdistally when the base 8510 is in a first position and the proximal-mostset of base retention recesses 8134 are configured to prevent the base8510 from moving distally when the base 8510 is in a second position.Similarly stated, the proximal base retention recesses 8134 and the baseconnection knobs 8518 cooperatively to limit movement of the base toprevent undesirable movement of the base 8510 after the medical injector8000 is actuated. The proximal base retention recesses 8134 and the baseconnection knobs 8518 also provide a visual cue to the user that themedical injector 8000 has been used.

The base rail grooves 8114 receive the guide members of the base 8510.The guide members of the base 8510 and the base rail grooves 8114 of thehousing 8100 engage each other in a way that allows the guide members ofthe base 8510 to slide in a proximal and/or distal direction within thebase rail grooves 8114 while limiting lateral movement of the guidemembers. This arrangement allows the base 8510 to move in a proximaland/or distal direction with respect to the housing 8100 but preventsthe base 8510 from moving in a lateral direction with respect to thehousing 8100.

The medicament container assemblies 4200 of the medical injector 8000are the same as those described above with reference to the medicalinjector 4000. The attachment of the elastomeric members 4217 to thedistal member 8320 of the gas venting assembly 8310 is similar to thatdescribed above with reference to the medical injector 4000, and istherefore not described in detail below.

The delivery mechanism 8300 includes a gas vent assembly 8310 (alsoreferred to as an expandable assembly), but does not rely on a piston orrigid member to move the elastomeric members 4217 within the containerbodies 4210 to inject the medicament. Rather, the elastomeric members4217 are moved by the force produced by the pressurized gas within thegas chambers (or medicament cavities 8139A, 8139B). Accordingly, thestroke length and/or the dosage amount can be set by the expanded lengthof the gas vent assembly 8310. In this manner, the length of themedicament container assemblies 4200 and the length of the gas ventassembly 8310 can be configured such the desired dosage amount isdelivered. Moreover, because the gas vent assembly 8310 moves from acollapsed to an expanded configuration, the medicament deliverymechanism 8300 can fit within the same housing 8100 regardless of thefill volume, the delivery volume and/or the ratio of the fill volume tothe delivery volume. In this manner, the same housing and productiontooling can be used to produce devices having various dosages of themedicament. For example, in a first embodiment (e.g., having a fillvolume to delivery volume ratio of 0.4), the medicament container has afirst length and the second movable member has a first length. In asecond embodiment (e.g., having a fill volume to delivery volume ratioof 0.6), the medicament container has a second length shorter than thefirst length, and the second movable member has a second length longerthan the first length. In this manner, the stroke of the device of thesecond embodiment is longer than that of the device of the firstembodiment, thereby allowing a greater dosage. The medicament containerof the device of the second embodiment, however, is shorter than themedicament container of the device of the first embodiment, therebyallowing the components of both embodiments to be disposed within thesame housing and/or a housing having the same length.

In some embodiments, the device 8000 is configured such that a ratio ofthe housing length H_(L) to the container length H_(C) is less thanabout 1.5. In other embodiments, the device 8000 is configured such thata ratio of the housing length H_(L) to the container length H_(C) isless than about 1.25. In yet other embodiments, the device 8000 isconfigured such that a ratio of the housing length H_(L) to thecontainer length H_(C) is less than about 1.1.

In some embodiments, the device 8000 is configured such that a ratio ofthe housing length H_(L) to a sum of the container length H_(C), thecarrier distance, and the stroke is less than about 1.1. In otherembodiments, the device 8000 is configured such that a ratio of thehousing length H_(L) to a sum of the container length H_(C), the carrierdistance, and the stroke is less than about 1.0. In yet otherembodiments, the device 8000 is configured such that a ratio of thehousing length H_(L) to a sum of the container length H_(C), the carrierdistance, and the stroke is less than about 0.9.

As shown in FIGS. 65 and 73 , the system actuator assembly 8500 includesthe base 8510, a release member 8550 and a spring 8576. FIG. 65 showscertain internal components of the medical injector 8000 without thebase 8510 and the safety lock 8700 so that the release member 8550 canbe more clearly shown. The release member 8550 has a proximal endportion 8551 and a distal end portion 8552, and is movably disposedwithin the distal end portion of the gas container cavity 8151. Theproximal end portion of the release member 8550 includes a sealingmember 8574 and a puncturer 8575. The sealing member 8574 is configuredto engage the sidewall of the housing 8100 defining the gas containercavity 8151 such that the proximal end portion of the gas containercavity 8151 is fluidically isolated from the distal end portion of thegas container cavity 8151. In this manner, when gas is released from thegas container 8410, the gas contained in the proximal end portion of thegas container cavity 8151 is unable to enter the distal end portion ofthe gas container cavity 8151. The puncturer 8575 of the release member8550 is configured to contact and puncture a frangible seal 8413 on thegas container 8410 when the release member 8550 moves proximally withinthe gas container cavity 8151.

The distal end portion 8552 of the release member 8550 includesextensions 8553. The extensions 8553 have projections that includetapered surfaces and engagement surfaces. Further, the extensions 8553define an opening between the adjacent extensions 8553. The engagementsurfaces are configured to extend through the release member apertureand contact the release member contact surface of the housing 8100, asshown in FIG. 73 . In this manner, the engagement surfaces limitproximal movement of the release member 8550.

The opening defined by the extensions 8553 is configured to receive thesafety lock protrusion 8702 of the safety lock 8700 (see e.g., FIGS. 70and 71 ) when the safety lock 8700 is coupled to the housing 8100 and/orthe base 8510. The safety lock protrusion 8702 is configured to preventthe extensions 8553 from moving closer to each other. Said another way,the safety lock protrusion 8702 is configured to ensure that theextensions 8553 remain spaced apart and the engagement surfaces remainin contact with the release member contact surface of the housing 8100.In some embodiments, for example, the release member 8550 and/or theextensions 8553 can be constructed from any suitable material configuredto withstand deformation that may occur when exposed to a load over anextended period of time.

The tapered surfaces of the extensions 8553 are configured to contactcorresponding tapered surfaces 8557 of the base 8510 when the base 8510is moved proximally relative to the housing 8100. Accordingly, when thebase 8510 is moved proximally relative to the housing 8100, theextensions 8553 are moved together by the tapered surfaces. The inwardmovement of the extensions 8553 causes the release member 8550 todisengage the release member contact surface 8126 of the housing 8100,thereby allowing the release member 8550 to be moved proximally alongits longitudinal axis as the spring 8576 expands (see FIG. 37 ).

The gas container 8410 includes a distal end portion 8411 and a proximalend portion 8412, and is configured to contain and/or produce apressurized gas. The distal end portion 8411 of the gas container 8410contains a frangible seal 8413 configured to break when the puncturer8575 of the release member 8550 contacts the frangible seal 8413. Thegas container retention member 8180 of the proximal cap 8110 of thehousing 8100 is configured to receive and/or retain the proximal endportion 8412 of the gas container 8410. Said another way, the positionof the gas container 8410 within the gas container cavity 8151 ismaintained by the gas container retention member 8180. As shown in FIGS.16 and 17 , the length of the gas container retention member 8180 andthe length of the release member 8550 collectively determine thedistance between the puncturer 8575 and the frangible seal 8413 when themedical injector 8000 is in the storage configuration. Accordingly, thisdistance, which is the distance through which the puncturer 8575 travelswhen the medical injector 8000 is actuated, can be adjusted by changingthe length of the gas container retention member 8180 and/or the lengthof the release member 8550. In some embodiments, the actuation timeand/or the force exerted by the puncturer 8575 on the frangible seal8413 can be adjusted by changing the distance between the puncturer 8575and the frangible seal 8413.

The medicament delivery mechanism 8300 includes two carrier assemblies4390 and a gas vent assembly 8310. The carrier assemblies 4390 and thegas vent assembly 8310 are each movably disposed within the medicamentcavities 8139A, 8139B of the housing 8100. The carrier assemblies 4390included within the medical injector 8000 are substantially the same asthose described above with reference to the medical injector 4000, andtherefore are not described in detail herein. For example, as describedabove with reference to the medical injector 4000, each carrier body4360 has a proximal surface 4376, forms a portion of the boundary of itsrespective gas chamber (i.e., the portion of the respective medicamentcavity 1139A, 1139B within which the pressurized gas flows). In thismanner, the pressurized gas produces a force on the proximal surfaces4376, which moves each carrier assembly 4390 distally within the housing8110.

Further, as described above, each carrier assembly 4390 includes aretraction spring 4380 that is disposed within the spring pocket 4363defined by the outer surface of each carrier body 4360, as shown in FIG.24 . Thus, each of the carrier assemblies 4390 within the medicalinjector 8000 is separately retracted (i.e., is retracted independentlyfrom the other carrier assembly therein). In other embodiments, however,the medical injector 8000 can include a single retraction spring and/orbiasing mechanism to retract both carrier assemblies therein.

The gas vent assembly 8310 is configured to expand and/or changeconfigurations during operation of the medical injector 8100, andselectively produces a pathway through which pressurized gas escapes themedicament cavities 8139A, 8139B after delivery of the medicament. Byreleasing or removing the force from the carrier bodies 4360 and/or themedicament container assemblies 4200, the retraction springs 4380 canmove the carrier bodies 4360 proximally to retract the needles 4216.Notably, the gas vent assembly 8310 does not exert a distal force on theelastomeric members 4217, but rather, is carried distally by eachelastomeric member 4217 during delivery of the medicament. Thus, thisarrangement is considered a “pistonless” delivery system, because theforce for insertion and medicament delivery is provided by thepressurized gas acting directly upon the medicament container assemblies4200 (e.g., the proximal surface 4218 of the elastomeric member 4217)and/or the carrier assemblies 4390 (e.g., the proximal surface 4376 ofthe carrier body 4360).

As shown in FIGS. 69 , the gas vent assembly 8310 includes two first (ordistal) members 8320, two second (or central) members 8330, and a third(or proximal) member 8340. These components are nested together suchthat the gas vent assembly 8310 can be transitioned from a collapsedconfiguration to an expanded configuration, and a series of partiallyexpanded configurations therebetween. When the gas vent assembly 8310 isin the expanded configuration (FIG. 77 , after delivery of themedicament), the opening 8112, the O-ring 8113 and the passageway 8346collectively allow the gas to escape the medicament cavities 8139A,8139B, such that needle retraction can occur.

The first member 8320 includes a proximal end portion 8322 and a distalend portion 8321. The distal end portion 8321 includes a protrusion 8323configured to matingly engage the elastomeric member 4217. In thismanner, movement of the elastomeric member 4217 distally causes movementof first member 8320 distally. The proximal end portion 8322 includes apair of retention walls 8324 configured to engage a corresponding distalend surface 8333 of the second (or central) member 8330. Moreparticularly, the first member 8320 defines an opening within which thesecond member 8330 can slide. The retention walls 8324 limit movement ofthe second member 8330.

The second member 8330 includes a proximal end portion 8332 and a distalend portion 8331. The distal end portion 8331 includes the distal endsurface 8333 that engages the first member 8320. The second memberdefines an opening 8335 and a pair of side grooves 8336. The third (orproximal) member 8340 is movably disposed within the opening 8335. Inparticular, the distal protrusions 8343A, 8343B of the third member 8340slide within the side grooves 8336 and contact the proximal end portion8332 to limit movement of the third member 8340 within the second member8330.

The third member 8340 includes a proximal end portion 8342 and twodistal end legs 8341A, 8341B. The distal end leg 8341A includes thedistal protrusions 8343A that engage one of the second members 8320. Thedistal end leg 8341B includes the distal protrusions 8343B that engagethe other second member 8320. The proximal end portion 8342 includes aguide surface 8344, a central portion 8348, and a valve portion 8345.The guide surface 8344 slides within the slots 8116 of the guide wall8115. The central portion 8348 connects each of the two distal end legs8341A, 8341A. The valve portion 8345 defines a passageway 8346.

As shown in FIGS. 70 and 71 , the safety lock 8700 includes a safetylock protrusion 8702 and an engagement portion 8720. As described above,when the safety lock 8700 is in a first (locked) position, the safetylock protrusion 8702 is configured to be disposed in the opening definedby the extensions 8553 of the release member 8550. Accordingly, thesafety lock protrusion 8702 is configured to prevent the extensions 8553from moving closer to each other, thereby preventing proximal movementof the release member 8550 and/or delivery of the medicament.

The safety lock 8700 includes engagement tabs 8722 that extend from asurface of the engagement members. The tabs 8722 engage the ribs 4236 ofthe sheath cover 4235 to limit relative movement between the safety lock8700 and the needle sheath assembly 4220, as described above. In thismanner, the needle sheath assembly 4220 can protect the user from theneedle 4216 and/or can keep the needle 4216 sterile before the useractuates the medical injector 8000, and the needle sheath assembly 4220can be removed from about the needle 4216 when the safety lock 8700 isremoved.

The outer surface of the safety lock 8700 include a grip portion(lateral ribs) and indicia thereon. The grip portion provides an areafor the user to grip and/or remove the safety lock 8700 from about thehousing 8100. The indicia provide instruction on how to remove thesafety lock 8700. In some embodiments, for example, indicia can indicatethe direction the user should pull the safety lock 8700 to remove thesafety lock 8700.

FIG. 72 shows the base (or actuator) 8510 of the medical injector 8000.The base 8510 includes a proximal (or inner) surface 8511, a distal (orouter) surface, and base connection knobs 8518. The distal surface isdisposed against a target surface (not shown) during use of the injector8000. As described below, the housing 8100 is moved distally relative tothe base 8510 and/or the distal surface, thereby causing the base 8510to move proximally relative to the housing 8100 to actuate the medicalinjector 8000. The base 8510 defines two needle apertures 8513A, 8513B,and a safety lock protrusion aperture 8514. The needle aperture 8513 isconfigured to receive the needle 8216 when the medical injector 8000 isactuated. The safety lock protrusion aperture 8514 of the base 8510receives the safety lock protrusion 8702 of the safety lock 8700 whenthe safety lock 8700 is coupled to the housing 8100 and/or the base8510.

The proximal surface 8511 of the base 8510 includes guide members (notshown) and protrusions 8515. The guide members of the base 8510 engageand/or slide within the base rail grooves 8114 of the housing 8100, asdescribed above. The protrusions 8515 of the base 8510 engage thetapered surfaces of the extensions 8553 of the release member 8550. Asdescribed in further detail herein, when the safety lock 8700 is removedand the base 8510 is moved in a proximal direction with respect to thehousing 8100, the protrusions 8515 of the base 8510 are configured tomove the extensions 8553 of the release member 8550 closer to eachother, actuating the medicament delivery mechanism 8300. As describedabove, the base connection knobs 8518 engage the base retention recesses8134 in a way that allows proximal movement of the base 8510 but limitsdistal movement of the base 8510.

The medical injector 8000 can be moved from the first configuration(FIGS. 66 and 67 ) to a second configuration (FIG. 73 ) by moving thesafety lock 8700 from a first position to a second position. The safetylock 8700 is moved from a first position to a second position by movingand/or removing the safety lock 8700 distally with respect to thehousing 8100. When the safety lock 8700 is moved from the first positionto the second position, the safety lock protrusion 8702 is removed frombetween the extensions 8553 of the release member 8550, thereby enablingthe medicament delivery mechanism 8300. As shown in FIG. 66 , prior toactuation, a portion of the medicament container assemblies 4200 can beviewed via the status apertures 8130A, 8130B. Specifically, thecontainer bodies 4210 and the contents therein (e.g., the medicament)can be viewed. As described above, in some embodiments, the housing 8100can include a label or other indicia providing a color strip (againstwhich the medicament can be compared), instructions for viewing or thelike. Although not shown in FIG. 18 , in some embodiments, a portion ofthe elastomeric members 4217 are visible via the status apertures 8130A,8130B.

After the safety lock 8700 is moved from the first position to thesecond position, the medical injector 8000 can be moved from the secondconfiguration (FIG. 73 ) to a third configuration (FIG. 74 ) by movingthe base 8510 from a first position to a second position. Similarlystated, the medical injector 8000 can be actuated by the system actuatorassembly 8500 by moving the base 8510 proximally relative to the housing8100. The base 8510 is moved from its first position to its secondposition by placing the medical injector 8000 against the body of thepatient and moving the base 8510 with respect to the housing 8100.Specifically, as described above the base includes a “contact portion”(i.e., the distal surface) that can be placed against and/or in contactwith the target location. Moving the base 8510 from the first positionto the second position causes the base 8510 to engage the extensions8553 of the release member 8550, thereby moving the extensions 8553together. The inward movement of the extensions 8553 causes engagementsurface of the release member 8550 to become disengaged from the housing8100, thereby allowing the release member 8550 to be moved proximallyalong its longitudinal axis as the spring 8576 expands.

When the base 8510 is moved from the first position to the secondposition, the system actuator assembly 8500 actuates the medicamentdelivery mechanism 8300, thereby placing the medical injector 8000 inits fourth configuration (i.e., the needle insertion configuration), asshown in FIG. 75 . More particularly, when the medical injector 8000 isin its fourth configuration, the puncturer 8575 of the release member8550 is in contact with and/or disposed through the frangible seal 8413of the gas container 8410.

After the frangible seal 8413 has been punctured, an actuating portionof a compressed gas flows from the gas container 8410, via the gaspassageway and into the medicament cavity 8139A and the medicamentcavity 8139B. The gas applies gas pressure to flanges 4214 of themedicament containers and/or the top surface of the carrier bodies 4360.Because the seals 4371, 4372 and the outer seal 4370 maintain theirrespective medicament cavities 8139A, 8139B fluidically isolated fromthe exterior of the device, the gas pressure exerts a force to move eachcarrier assembly 4390 distally within the respective medicament cavities8139A, 8139B, as shown in FIG. 75 . In this manner, the movement of theneedles 4216 in a distal direction causes the distal end portion of eachneedle 4216 to exit the housing 8100 and enter the body of a patientprior to administering the medicament.

As shown in FIG. 75 , when the device moves from the third configurationto the fourth configuration, the gas vent assembly expands from itscollapsed configuration (FIGS. 66, 73 ) to a partially expandedconfiguration. Notably, in the partially expanded configuration, thevalve portion 8345 is maintained in a sealed position within the opening8112 and the O-ring 8113. Thus, the medicament cavities 8139A, 8139B aremaintained in fluidic isolation.

When the needles 4216 have extended by a desired distance, the distalsurfaces 4365A, 4365B of each carrier body 4360 contacts theirrespective end surfaces 8106A, 8106B of the housing 8100 to limitfurther distal movement of the carrier assemblies 4390 within thehousing 8100. When the distal movement of the carrier assemblies 4390 isprevented, the gas within the medicament cavities 8139A, 8139B (i.e.,the gas chamber) continues to apply gas pressure to the respectiveelastomeric members 4217. This causes the elastomeric members 4217 (andtherefore the respective first members 8320 of the gas vent assembly8310) to move in the distal direction with the medicament containerbodies 4210. Distal movement of the elastomeric members 4217 generates apressure upon the medicament contained within the medicament containerassemblies 4200, thereby allowing at least a portion of the medicamentto flow out of each medicament container 4200 via its needle 4216. Themedicament is delivered to a body of a user via the medicament deliverypath defined by the medicament container 4200 and the needle 4216. Atthe end of injection, the medical injector is in its fifth configuration(FIG. 76 ).

Moreover, as shown in FIG. 76 , the distal legs 8341A, 8341B areflexible and thus allow the vent assembly 8310 to expand in a manner inwhich the two elastomeric members 4217 are not moving at substantiallythe same location in within their respective container bodies 4210. Thisarrangement allows for the vent assembly 8310 to expand without beingover-constrained. In other embodiments, however, the medicament can beinjected substantially simultaneously.

When the medical injector 8000 is in its fifth configuration, a portionof the medicament container assemblies 4200, a portion of the carrierbodies 4360, and a portion of the gas vent assembly 8310 can be viewedvia the status apertures 8130A, 8130B. As described above, in someembodiments, the housing 8100 can include a label or other indiciaproviding a color strip to assist the user in identifying the carrier,providing instructions for viewing, or the like. In some embodiments, aportion of the elastomeric members 4217 are visible via the statusapertures 8130A, 8130B when the medical injector 8000 is in its fifthconfiguration.

As shown in FIGS. 76 and 77 , as the elastomeric members 4217 movedistally, the gas vent assembly 8310 continues to move to its fullyexpanded configuration. After the elastomeric members 4217 has moved apredetermined distance within their respective medicament container body4210 (corresponding to the desired dose), the valve portion 8345 ismoved from within the opening 8112 thereby allowing the pressurized gascontained within the gas chambers (i.e., the volume within themedicament cavities 8139A, 8139B between the proximal end of the housing8100 and the surface of the respective carrier 4360) to escape via thepassageway 8346 and the opening 8112. After the gas pressure within themedicament cavities 8139A, 8139B decreases below a certain level, theforce exerted by the retraction springs 4380 on each carrier body 4360is sufficient to cause each carrier body 4360 to move proximally withinthe housing 8100 (i.e., to retract). This places the medical injector inits sixth configuration (FIGS. 78 ).

When the medical injector 8000 is in its sixth configuration, a portionof each medicament container assembly 4200 can be viewed via the statusapertures 8130A, 8130B. For example, the container body 4210 and aportion of the elastomeric member 4217 can be visible via the statusapertures 8130A. 8130B. As described above, in some embodiments, thehousing 8100 can include a label or other indicia providing a colorstrip to assist the user in identifying the elastomeric member,providing instructions for viewing, or the like. In some embodiments, aportion of the carriers 4360 can be visible via the status apertures8130A, 8130B when the medical injector 8000 is in its sixthconfiguration.

FIGS. 79 and 80 are perspective views of a medical injector 9000according to an embodiment. The medical injector 9000 is characterizedby having front status windows 9130A, 9130B and rear status windows9160A, 9160B through which the medicament containers 9200 therein can beviewed. The operation of, and certain components within, the medicalinjector 9000 are similar in many respects to that of the medicalinjector 8000, and thus certain aspects are not described in detailherein. One way that the medical injector 9000 differs from the medicalinjector 8000 is that the dual-container medical injector 9000 includesthe energy storage member on one side of the injector and the twomedicament container assemblies 9200 on the other side of the injector.

Although the medical injector 5000′ and the medical injector 5000 areshown and described as including an electronic circuit system integratedwithin the housing of the device, in other embodiments, the electroniccircuit system can be an external, discrete component that is affixed tothe device. For example, FIGS. 81-85 are various views of a medicalinjector assembly 10000 according to an embodiment. The medical injectorassembly 10000 includes a medical injector 4000 and an electroniccircuit system 10900. The electronic circuit system includes anelectronics housing 10170 within which the electrical components and/orcircuitry is disposed. The electronic circuit system 10900 can includeany suitable electronic components (e.g., printed circuit boards,sensors, resistors, capacitors, inductors, switches, microcontrollers,microprocessors and/or the like) operatively coupled to produce and/oroutput the desired electronic signals and/or to perform the functionsdescribed herein. For example, the electronic circuit system can includeany of the features of and/or perform any of the functions of any of theelectronic circuit systems disclosed U.S. Pat. No. 8,226,610, entitled“Medical Injector with Compliance Tracking and Monitoring,” U.S. Pat.No. 8,361,026, entitled “Apparatus and Methods for Self-administrationof Vaccines and Other Medicaments,” and U.S. Patent Publication No.2014/0243749, filed on Dec. 27, 2013 and entitled “Devices, Systems andMethods for Locating and Interacting with Medicament Delivery Systems,”the entirety of each of which is incorporated by reference herein.

The electronic housing 10170 includes a coupling portion 10172, a gripportion 10174, and a status aperture 10173. The coupling portion 10172is configured to be removably coupled to the housing 4100 of the medicalinjector 4000. In this manner, the medical injector 4000 can bedistributed separately and the electronic circuit system 10900 can belater coupled to the medical injector. This also allows for theelectronic circuit system 10900 to be reused (i.e., used with more thanone different delivery device). The coupling portion 10172 can includeany suitable protrusions, recesses, and other features to suitably becoupled to the medical injector 4000. Moreover, when the electronichousing 10170 is coupled to the medical injector 4000, the front statuswindow 4130 of the medical injector 4000 is viewed. Additionally, theelectronic housing 10170 defines the status aperture 10173, which isaligned with the rear status window 4160 of the medical injector 4000.

The grip portion 10174 provides a location at which a user can grasp theelectronic housing 10170 to manipulate the medical injector 4000.

FIGS. 86-89 are various views of a medical injector assembly 11000according to an embodiment. The medical injector assembly 11000 includesa medical injector 4000 and an electronic circuit system 11900. Theelectronic circuit system includes an electronics housing 11170 withinwhich the electrical components and/or circuitry is disposed. Theelectronic circuit system 11900 can include any suitable electroniccomponents (e.g., printed circuit boards, sensors, resistors,capacitors, inductors, switches, microcontrollers, microprocessorsand/or the like) operatively coupled to produce and/or output thedesired electronic signals and/or to perform the functions describedherein. For example, the electronic circuit system can include any ofthe features of and/or perform any of the functions of any of theelectronic circuit systems disclosed U.S. Pat. No. 8,226,610, entitled“Medical Injector with Compliance Tracking and Monitoring,” U.S. Pat.No. 8,361,026, entitled “Apparatus and Methods for Self-administrationof Vaccines and Other Medicaments,” and U.S. Patent Publication No.2014/0243749, filed on Dec. 27, 2013 and entitled “Devices, Systems andMethods for Locating and Interacting with Medicament Delivery Systems,”the entirety of each of which is incorporated by reference herein.

The electronic housing 11170 includes a coupling portion 11172, a gripportion 11174, and a status aperture 11173. The coupling portion 11172is configured to be removably coupled to the housing 4100 of the medicalinjector 4000. In this manner, the medical injector 4000 can bedistributed separately and the electronic circuit system 11900 can belater coupled to the medical injector. This also allows for theelectronic circuit system 11900 to be reused (i.e., used with more thanone different delivery device). The coupling portion 11172 can includeany suitable protrusions, recesses, and other features to suitably becoupled to the medical injector 4000. Moreover, when the electronichousing 11170 is coupled to the medical injector 4000, the front statuswindow 4130 of the medical injector 4000 is viewed. Additionally, theelectronic housing 11170 defines the status aperture 11173, which isaligned with the rear status window 4160 of the medical injector 4000.

The grip portion 11174 provides a location at which a user can grasp theelectronic housing 11170 to manipulate the medical injector 4000.

Although the medical injector assemblies 10000 and 11000 are shown anddescribed as including the medical injector 4000, in other embodiments,the medical injector assemblies 10000 and 11000 can include any suitablemedicament delivery device of the types shown and described herein.Similarly stated, the electronic circuit system 10900 can be used withand/or coupled to any of the medicament delivery devices shown anddescribed herein.

In some embodiments, any of the devices shown and described herein canbe used to deliver a medicament. For example, FIG. 90 is a flow chart ofa method 100 of delivering a medicament via a “dual container” device,according to an embodiment. The method includes placing a housing of amedical injector into contact with a target location, 14. The housingdefines a gas chamber, and encloses an energy storage member, a firstmedicament container assembly, and a second medicament containerassembly. The first medicament container assembly includes a firstcontainer body, a first elastomeric member disposed within the firstcontainer body, and a first needle coupled to a distal end portion ofthe first container body. The first needle is disposed within thehousing. The second medicament container assembly includes a secondcontainer body, a second elastomeric member disposed within the secondcontainer body, and a second needle coupled to a distal end portion ofthe second container body. The second needle is disposed within thehousing. The medical injector can be any of the medical injectors shownand described herein, such as, for example, the medical injector 8000.

In some embodiments, the method 100 optionally includes removing, beforethe placing, an actuator guard from an end portion of the housing, 10.The actuator guard, which can be an of the guards or safety locksdescribed herein (e.g., safety lock 8700) is configured to limitmovement of the actuator when the actuator guard is coupled to thehousing.

In some embodiments, the method 100 optionally includes viewing, beforethe placing, the first medicament within the first container body via afirst status window defined by the housing, 12.

The method includes actuating the energy storage member to produce apressurized gas within the gas chamber of the housing, 16. The firstmedicament container assembly moves within the housing in response to aforce exerted by the pressurized gas such that the first needle movesfrom within the housing to an exterior volume outside of the housing.The first elastomeric member moves within the first container body toconvey a first medicament contained therein in response to the force.The second medicament container assembly moves within the housing inresponse to the force exerted by the pressurized gas such that thesecond needle moves from within the housing to the exterior volume. Thesecond elastomeric member moves within the second container body toconvey a second medicament contained therein in response to the force.

In some embodiments, the method optionally includes removing the housingfrom contact with the target location after the first medicament and thesecond medicament are each conveyed, 18. This allows the first needleand the second needle to each be retracted within the housing, asdescribed above.

While various embodiments of the invention have been described above, itshould be understood that they have been presented by way of exampleonly, and not limitation. Where methods described above indicate certainevents occurring in certain order, the ordering of certain events may bemodified. Additionally, certain of the events may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above.

For example, any of the devices shown and described herein can includean electronic circuit system to provide user instruction and/orfeedback. In some embodiments the electronic circuit system can beintegral to the device (e.g., included within the housing, such as thehousing 1100). In other embodiments, the electronic circuit system canbe an external, discrete component that is affixed to the device.

For example, any of the elastomeric members described herein can beconstructed from any suitable material or combination of differentmaterials. For example, in some embodiments, at least a portion of anyof the elastomeric members described herein (e.g., the elastomericmembers 1217, 2217, 3217, 4217) can be coated. Such coatings caninclude, for example, polydimethylsiloxane. In some embodiments, atleast a portion of any of the elastomeric members described herein canbe coated with polydimethylsiloxane in an amount of betweenapproximately 0.02 mg/cm² and approximately 0.80 mg/cm².

Any of the medicament container assemblies described herein can have anysuitable size (e.g., length and/or diameter) and can contain anysuitable volume of the medicament. In some embodiments, any of themedicament container assemblies described herein (including themedicament container assemblies 1200, 2200, 3200, 4200, 5200, 6200, and7200) can be a prefilled (or prefillable) syringe, such as thosemanufactured by Becton Dickinson, Gerresheimer, Ompi Pharma or others.For example, in some embodiments, the medicament container assembly 1200(and any of the medicament container assemblies described herein) can bea Becton Dickinson “BD Hypak Physiolis” prefillable syringe containingany of the medicaments described herein. Moreover, any of the medicamentdelivery devices and/or medical injectors described herein can beconfigured to inject any suitable dosage such as, for example, a dose ofup to 1 mL of any of the medicaments described herein. In otherembodiments, any of the medicament delivery devices and/or medicalinjectors described herein can be configured to inject a dose of up to 2mL, 3 mL, 4 mL, 5 mL, or more of any of the medicaments describedherein.

Any of the container bodies described herein can be constructed fromglass, and can be fitted and/or coupled to any suitable needle. Forexample, in some embodiments, any of the container bodies describedherein (including the container bodies 1210, 2210, 3210, 4210, 5210,6210, and 7210) can be coupled to a needle having any suitable size. Anyof the medicament container assemblies and/or prefilled syringesdescribed herein can be coupled to a needle having a gauge size of 21gauge, 22 gauge, 23 gauge, 24 gauge, 25 gauge, 26 gauge, 27 gauge, 28gauge, 29 gauge, 30 gauge, or 31 gauge. Any of the medicament containerassemblies and/or prefilled syringes described herein can be coupled toa needle having any suitable length, such as, for example, a length ofabout 0.2 inches, about 0.27 inches, about 0.38 inches, about 0.5inches, about 0.63 inches, about 0.75 inches, or more. In someembodiments, any of the medicament containers and/or prefilled syringesdescribed herein can be coupled to a 29 gauge, needle having a length ofapproximately 0.5 inches. Moreover, any of the medicament containersand/or prefilled syringes described herein can include a staked needleat the distal end thereof

Although the dual container devices shown and described herein (e.g.,the medical injector 8000), are shown as including two substantiallyidentical medicament container assemblies (e.g., the container assembly4200), in other embodiments, a dual container delivery device caninclude two different medicament containers, each containing a differentsubstance, having a different size, and/or having a different needle(different needle length, needle gauge or the like).

For example, although the medical injector 4000 is shown as having acarrier assembly 4390 that includes multiple O-ring seals, in otherembodiments, any suitable sealing mechanism can be included. Forexample, in some embodiments, a carrier assembly can include anovermolded portion to form a seal with the housing and/or the medicamentcontainer body. In some embodiments, a carrier assembly need onlyinclude one seal between the flange of the medicament container body andthe inner surface of the carrier body.

For example, any of the medical injectors shown and described herein caninclude a base (or distal actuator) having a mechanism for cooling thesurface of the target injection site. By cooling the target injectionsite, patient comfort during an injection operation can be improved.Such cooling mechanisms can include, for example, an electronic cooler(e.g., a thermo-electric cooler) that is triggered upon removal of asafety guard, a chemical or spray that is emitted by the base uponremoval of the safety guard, or any other suitable mechanism.

Any of the medical injectors shown and described herein can include abase (or distal actuator) having a mechanism for expanding, stretchingor otherwise pulling taut a patient's skin at or near an injection site.In other embodiments, the base (or distal actuator) of any of theinjectors described herein can include a mechanism that increases thesurface area of the base (or distal actuator) against the injectionsite. For example, in some embodiments a base can include a series ofgrips, protrusions, microneedles, or the like that can grip the skin andexpand to stretch the surface prior to actuation and/or injection orallow for a large surface area of contact against the skin for addedstability for injectate administration. In other embodiments, a base caninclude a series of grips, protrusions, microneedles, or the like thatcan grip the skin and pinch the surface together prior to actuationand/or injection. Such a base can include a dome or other structure topinch certain portions of the anatomy, such as, for example, theabdomen.

Although the medicament injectors shown and described above include adelivery mechanism (e.g., 1300) including the release of a pressurizedgas, in other embodiments, a medicament delivery device can include anysuitable method of delivery of a medicament disposed within. Forexample, in some embodiments, any of the devices described herein caninclude a mechanical energy storage (e.g. spring, gears, racks, pinions,pulleys, or the like) member, rather than a compressed gas container. Inother embodiments, any of the devices described herein can include anyother suitable energy storage member (e.g., magnetic, electrical,propellant based, chemical reaction based, or the like).

While the medical injectors herein are described as being “pistonless”gas-powered auto-injectors, in other embodiments, any of the medicalinjectors can include any suitable energy storage member configured toproduce a force directly on a medicament container and/or a carrier (asdescribed, for example, in the '849 patent). For example, in someembodiments, a medical injector can include one or more bias members,springs, and/or any other suitable mechanical drives (as describedabove) configured to exert a force on one or more medicament containers.By way of example, a medical injector can include a first springconfigured to produce a force on a first medicament container and asecond spring configured to produce a force, substantially equal to theforce produced by the first spring, on a second medicament container.Moreover, the first spring and the second spring can be actuatedsubstantially concurrently and/or via the same actuation event such thatthe first spring and second spring move the first medicament containerand the second medicament container substantially concurrently.

Although some of the “dual container” injectors have been describedabove as being moved in response to a force produced by a single energystorage and/or the same type of energy storage member, in otherembodiments, a medicament container can include any suitable combinationof energy storage members. For example, in some embodiments, a medicalinjector can include a first compressed gas container configured torelease a volume of compressed gas to move a first medicament containerrelative to a housing, and a second compressed gas container configuredto release a volume of compressed gas to move a second medicamentcontainer relative to the housing. In other embodiments, a medicalinjector can include a compressed gas container configured to release avolume of compressed gas and a spring configured to transition from afirst configuration to a second configuration. In such embodiments, forexample, the first medicament container can be moved in response to aforce associated with the expansion of the compressed gas while thesecond medicament container can be moved in response to a forceassociated with the transitioning of the spring from the firstconfiguration to the second configuration (or vice versa). In otherembodiments, the forces produced by the expansion of the compressed gasand the transitioning of the spring can be collectively exerted on boththe first medicament container and the second medicament container.

Although the “dual container” injector 8000 has been described above asincluding a compressed gas container, in other embodiments, the medicalinjector 8000 and any of the injectors described herein, can use anysuitable energy storage member of the types shown and described herein.

Although the embodiments have been particularly described above asmoving the medicament containers in a substantially concurrent injectionevent, in other embodiments, a medical injector can be configured for a“staged” (or sequential) injection event. For example, in someembodiments, a medical injector can include a first energy storagemember (such as any of those described herein) configured to exert aforce on a first medicament container and a second energy storage member(similar to or different from the first energy storage member)configured to exert a force on a second medicament container. In suchembodiments, actuation of the medical injector can result in the firstenergy storage member exerting the force on the first medicamentcontainer to initiate a first injection event, while the second energystorage member remains in a configuration associated with a greaterpotential energy (e.g., unactuated or the like). After a predeterminedtime after the actuation of the medical injector, the second energystorage member can exert the force on the second medicament container toinitiate a second injection event. By way of example, a medical injectorcan include a first compressed gas storage container configured torelease a volume of compressed gas to initiate an injection eventassociated with a first medicament container and a second compressed gasstorage container configured to release a volume of compressed gas toinitiate an injection event associated with a second medicamentcontainer. In such embodiments, actuation of the medical injector canresult in (1) the first gas storage container being punctured (oractuated) at a first time to initiate the injection event associatedwith the first medicament container and (2) the second gas storagecontainer being punctured (or actuated) at a second time, after thefirst time, to initiate the injection event associated with the secondmedicament container.

In other embodiments, the second energy storage member can exert theforce on the second medicament container in response to a secondactuation event. For example, a medical injector can include an actuator(e.g., a base or the like) configured to be actuated (e.g., moved) afirst amount and a second amount after the first amount. By way ofexample, a medical injector can include a base actuator configured to bemoved a first distance to actuate a first energy storage and a seconddistance to actuate a second energy storage member. In such embodiments,the movement of the base actuator can be substantially continuous. Thatis to say, the base actuator can be moved the second distance in asingle continuous motion and, while moving through a distancesubstantially equal to the first distance, can trigger an actuation ofthe first energy storage member. In other embodiments, the movement ofthe base actuator the first amount can be a discrete operation and themovement of the base actuator the second amount can be a discreteoperation.

In still other embodiments, the medical injector can include a firstactuator configured to actuate the first energy storage member and asecond actuator configured to actuate the second energy storage member.For example, in some embodiments, a user can manipulate the medicalinjector to actuate the first actuator (e.g., by moving a base or thelike, as described above), which in turn actuates the first energystorage member. After the first actuator is actuated, the user canmanipulate the second actuator, which in turn actuates the second energystorage member. In some embodiments, the first actuator can beconfigured to actuate the second actuator after an actuation event. Inother embodiments, the second actuator can be discretely and/orotherwise independently actuated by the user. For example, in someembodiments, a medical injector can include a first actuator disposed onor at a first end portion of the medical injector and can include asecond actuator disposed on or at a second end portion of the medicalinjector opposite the first end portion. In some such embodiments, thefirst actuator and the second actuator can be actuated and/or moved inresponse to forces exerted in the same direction while the medicalinjector is in a substantially constant orientation.

In other embodiments, a user can actuate the first actuator while themedical injector is in a first orientation and after an injection eventassociated with the first medicament container is complete, the user canflip the medical injector to a second orientation, substantiallyopposite the first orientation, to actuate the second actuator. In thismanner, a needle of a first medicament container can be configured toextend from a first end of the medical injector while a needle of asecond medicament container can be configured to extend from a secondend of the medical injector opposite the first end. In some embodiments,the second actuator can be in a locked configuration or the like untilcompletion of a retraction event of the first medicament container.Similarly, once the medical injector is reoriented, the first medicamentcontainer can be placed in a locked configuration. Moreover, when themedical injector is reoriented, the second actuator and/or secondmedicament container can be transitioned to an unlocked configuration toallow actuation of the second actuator and thus, an injection eventassociated with the second medicament container.

Although the medicament containers are described above as being actuated(either concurrently or independently) to perform an injection event ofa medicament directly into a patient, in other embodiments, an injectionevent of a first medicament container or a second medicament containerneed not result in direct injection of the medicament into the patient.For example, in some embodiments, a medical injector can include a firstmedicament container including a needle coupled to a distal end portionof the first medicament container, and a second medicament container influid communication with the first medicament container. In suchembodiments, actuation of the medical injector can result in, forexample, an injection event in which the second medicament containerinjects a volume of medicament contained therein into the firstmedicament container. Moreover, in a substantially simultaneous process,the first medicament container can be moved to insert the needle intothe patient. This arrangement can be such that a complete insertion ofthe needle into the patient substantially corresponds with and/or occurssubstantially at the same time as an injection of the medicament fromthe second medicament container into the first medicament container.

Although particular injection events, mechanisms, devices, and/orcomponents have been described herein, it is to be understood that theyhave been presented by way of example and not limitation. That is tosay, an auto-injector can include more than one medicament container andcan be configured to deliver at least one dose of a medicament to apatient in response any suitable actuation event and/or the like.

Any of the devices and/or medicament containers shown and describedherein can be constructed from any suitable material. Such materialsinclude glass, plastic (including thermoplastics such as cyclic olefincopolymers), or any other material used in the manufacture of prefilledsyringes containing medications.

Any of the devices and/or medicament containers shown and describedherein can contain and/or deliver a wide array of large ormacromolecular injectables that include carbohydrate-derivedformulations, lipids, nucleic acids, proteins/peptides (e.g. monoclonalantibodies) and other biotechnologically-derived medicaments. Forexample, anti-tumor necrosis factor agents such as infliximab,etanercept, adalimumab, golimumab, natalizumab, vedolizumab, andcertolizumab can be administered using the described auto-injectorheroin, Other macromolecular injectable medications that can beadministered using the device and/or medicament containers shown anddescribed herein include viscous medicaments that targetpro-inflammatory cytokines (e.g. IL-1, IL-2, IL-4, IL-5, IL-6, IL-12,IL-13, IL-23, IL-17, IL-21 and associated receptors) includingdupilumab, sarilumab, mepolizumab, benralizumab, reslizumab,lebrikizumab, ustekinumab, anrunkinzumab, bertilimumab, andtralokinumab. Large anti-adhesion molecules to treat a variety ofdiseases may be administered using the device and/or medicamentcontainers shown and described herein including etrolizumab andvatelizumab. Still other large and viscous monoclonal antibodies thatmay be administered using the device and/or medicament containers shownand described herein include tezepelumab, anifrolumab, omalizumab, andproprotein convertase subtilisin kexin type 9 (PCSK9) inhibitorsincluding alirocumab and evolocumab.

Any of the devices and/or medicament containers shown and describedherein can include any suitable medicament or therapeutic agent. In someembodiments, the medicament contained within any of the medicamentcontainers shown herein can be a vaccine, such as, for example, aninfluenza vaccine, a hepatitis vaccine, a haemophilus influenza Type B(HiB) vaccine, a measles vaccine, a mumps vaccine, a rubella vaccine, orcombination vaccine (e.g. measles, mumps and rubella, quadrivalent, orhexavalent vaccines), a polio vaccine, a human papilloma virus (HPV)vaccine, a tetanus vaccine, a diphtheria vaccine, a pertussis vaccine, abubonic plague vaccine, a yellow fever vaccine, a cholera vaccine, amalaria vaccine, a smallpox vaccine, a pneumococcal vaccine, a rotavirusvaccine, a varicella vaccine, a dengue fever vaccine, a rabies vaccineand/or a meningococcus vaccine. In other embodiments, the medicamentcontained within any of the medicament containers shown herein can be acatecholamine, such as epinephrine. In other embodiments, the medicamentcontained within any of the medicament containers shown herein can be anopioid receptor antagonist, such as naloxone, including any of thenaloxone formulations described in U.S. Pat. No. 8,627,816, entitled“Medicament Delivery Device for Administration of Opioid AntagonistsIncluding Formulation for Naloxone,” filed on Feb. 28, 2011. In yetother embodiments, the medicament contained within any of the medicamentcontainers shown herein can include peptide hormones such as insulin andglucagon; human growth hormone (HGH); sumatriptan; a corticosteroid suchas dexamethasone; ondansetron; an opioid agonist receptor modulatorssuch as fentanyl; a partial agonist opioid receptor modulators such asbuprenorphine; a mixed agonist/antagonist opioid receptor modulator suchas nalbuphine; a benzodiazepine such as diazepam, midazolam orlorazepam; erythropoiesis-stimulating agents (ESA) such as darbepoetinalfa; immunoglobulins including dual-variable domain immunoglobulins;interferons; anti-tumor; recombinant human granulocytecolony-stimulating factor (GCSF) such as pegfilgrastim; and othertherapies suitable for injection in mammals. In yet other embodiments,the medicament contained within any of the medicament containers shownherein can be a placebo substance (i.e., a substance with no activeingredients), such as water.

The medicament containers and/or medicament delivery devices disclosedherein can contain any suitable amount of any medicament. For example,in some embodiments, a medicament delivery device as shown herein can bea single-dose device containing an amount medicament to be delivered ofapproximately 0.4 mg, 0.8 mg, 1 mg, 1.6 mg or 2 mg. As described above,the fill volume can be such that the ratio of the delivery volume to thefill volume is any suitable value (e.g., 0.4, 0.6 or the like). In someembodiments, an electronic circuit system can include “configurationswitch” that, when actuated during the assembly of the delivery device,can select an electronic output corresponding to the dose containedwithin the medicament container.

Any of the medicament containers described herein can include anysuitable elastomeric member and/or plunger. For example, an elastomericmember can be formulated to be compatible with the medicament containedwithin a medicament container. Moreover, a medicament container caninclude any number of elastomeric members. For example, in someembodiments, a medicament container can include a dry portion of amedicament and a fluid portion of the medicament, configured to be mixedbefore injection. The piston portion of the medicament deliverymechanism can be configured to engage multiple elastomeric membersassociated with the portions of the medicament. In this manner, multipleelastomeric members can be engaged to mix the dry portion with the fluidportion of the medicament before the completion of an injection event.In some embodiments, for example, any of the devices shown and describedherein can include a mixing actuator similar to the mixing actuatorsshown and described in U.S. Pat. No. 9,173,999, entitled “Devices andMethods for Delivering Medicaments from a Multi-Chamber Container,”filed Jan. 25, 2012, which is incorporated herein by reference in itsentirety.

Although the injectors described herein have been shown and described asincluding mechanisms for needle retraction, in other embodiments any ofthe injectors shown and described herein can include a needle shieldthat extends distally after the injection to cover the exposed needle.Such a design may be used, for example, in a “pistonless” design asdiscussed above. For example, in some embodiments, a base of a medicalinjector (e.g. the base 4510 or the base 8510) can be (or include) anextending portion that, upon completion of the injection, extendsdistally to cover the needle. In some such embodiments, the gas ventassembly can divert all or a portion of the pressurized gas to a volumewithin the housing such that the diverted gas exerts a force on the base(or a portion of the base) to cause the base (or portion of the base) toextend distally to cover the needle. In other such embodiments, aspring, biasing member, or retraction member can propel the base (orportion of the base) distally.

For example, FIGS. 91-94 show schematic illustrations of a “dualcontainer” device 12000 according to an embodiment in a first, second,third and fourth configuration, respectively. The medicament deliverydevice 12000 includes a housing 12100, two medicament containers 12200Aand 12200B, an energy storage member 12400, a needle shield 12511, and avent member 12351. The housing 12100 defines a gas chamber 12139 thatreceives a pressurized gas from the energy storage member 12400. The gaschamber 12139 can be of any suitable size and shape, and can be, forexample, a portion of the volume defined by the housing 12100 withinwhich a portion of the first medicament container 12200A and/or thesecond medicament container 12200B are disposed. The vent member (ormechanism) 12351 can be an opening or valve, of the types shown anddescribed herein (e.g., with respect to the device 1000 and the device4000). In this manner, the gas pressure within the gas chamber 12139 canbe reduced upon completion of the injection event. The gas pressure canalso be used to move the needle shield 12511.

The housing 12100 can be any suitable size, shape, or configuration andcan be made of any suitable material. For example, in some embodiments,the housing 12100 is an assembly of multiple parts formed from a plasticmaterial and defines a substantially rectangular shape when assembled.In other embodiments, the housing 12100 can have a substantiallycylindrical shape.

The medicament containers 12200A, 12200B each have a container body thatdefines a volume that contains (i.e., is filled with or partially filledwith) a medicament. The distal end portion of each medicament container12200A, 12200B is coupled to a needle 12216A, 12216B, respectively,through which the medicament can be delivered. In some embodiments, themedicament container 12200A and the medicament container 12200B can eachbe a prefilled syringe having the needle 12216A, 12216B, respectively,staked thereto. Such prefilled syringes can be any of the types shownand described herein.

The medicament container 12200A and the medicament container 12200B eachinclude an elastomeric member 1217A, 1217B, respectively, that seals themedicament within the container body. The elastomeric members 1217A,1217B are configured to move within the container body to inject themedicament from the medicament container assembly 1200. The elastomericmembers 1217A, 1217B can be of any design or formulation suitable forcontact with the medicament, of the types shown and described herein.

Although the medicament container 12200A and the medicament container12200B are shown as being parallel to and noncoaxial with each other, inother embodiments, the medicament container 12200A and the medicamentcontainer 12200B can be arranged in any suitable manner within thehousing 12100. Moreover, although the medicament container 12200A andthe medicament container 12200B are shown as being disposed within thehousing 12100 without a carrier, in other embodiments, the medicamentcontainer 12200A and the medicament container 12200B can each bedisposed within a carrier (or set of carriers) to facilitate movementwithin the housing 12100.

The energy storage member 12400 is disposed within the housing 12100,and is configured to convey a pressurized gas into the gas chamber 12139produce a force F₁ (see FIGS. 51-53 ) to convey the contents of the twomedicament containers 12200A and 12200B when the energy storage member12400 is actuated. The energy storage member 12400 can be any suitablemember or device that stores potential energy and, when actuated,produces the pressurized gas. For example, the energy storage member12400 (and any of the energy storage members described herein) can beany of a device containing compressed gas, a device containing a vaporpressure-based propellant or the like.

Thus, when actuated the energy storage member 12400 produces a force F₁to deliver the medicament contained within the medicament containers12200A, 12200B. More specifically, the energy storage member 12400produces the force F₁ that moves the medicament containers 12200A,12200B from a first position to a second position in a first directionindicated by the arrow AA in FIG. 92 and/or that moves the plungers12217A, 12217B from a first plunger position to a second plungerposition as shown by the arrows BB in FIG. 93 . By including a singleenergy storage member 12400, a user can initiate delivery from bothmedicament containers via a single actuation operation.

In some embodiments, the energy storage member 12400 can be configurableto include various amounts of stored energy without changing the size ofthe energy storage member. In such embodiments, therefore, a high force(e.g., to inject viscous medicaments) can be achieved in the samepackaging that is used for lower viscosity medicaments. For example, insome embodiments, the energy storage member 12400 can be a compressedgas cylinder having any desired pressure (and thus, mass) of gastherein. Accordingly, the pressure and/or force (e.g., force F1) can beachieved to complete the operations described herein, regardless of themedicament.

As shown, the energy storage member 12400 is operably coupled (e.g., viathe gas chamber 12139) to the medicament containers 12200A, 12200Band/or the medicament therein such that the force F₁ delivers themedicament. In some embodiments, for example, the force Fi can betransmitted to the medicament containers and/or the medicament thereinvia a carrier or movable member (not shown). When the medicamentdelivery device 12000 is actuated to produce the force Fi, themedicament containers 12200A, 12200B move from the first position (seeFIG. 91 , which corresponds to the first configuration of the medicamentdelivery device 12000) to the second position (see FIG. 92 , whichcorresponds to the second configuration of the medicament deliverydevice 12000). As shown, the movement of the medicament containers12200A, 12200B within the housing 12100 results in a needle insertionoperation.

When the medicament containers 12200A, 12200B are in their respectivesecond positions, the pressure within the gas chamber continues to exerta force on the elastomeric members 12217A, 12217B. This causes eachelastomeric member 12217A, 12217B to move within its respectivecontainer body to expel the medicament therefrom, as shown by the arrowsBB in FIG. 93 . The movement of the elastomeric member 12217A, 12217Bplaces the medicament delivery device 12000 in a third configuration.

After the medicament is delivered, the vent member 12351 diverts and/orreleases a portion of the pressurized gas towards the needle shield12511. This produces an extension force F2 on the needle shield 12511,which moves the needle shield 12511 to cover the needles (e.g., thesecond and third configuration, as shown in FIGS. 92 and 93 ) in thedirection of the arrow CC.

In other embodiments, a portion of a needle sheath can be configured toremain within the housing during actuation, and then can be moveddistally to cover the exposed needle after completion of the deliveryevent.

Although the gas vent assemblies 4310 and 8310 are shown and describedherein as moving a valve portion relative to a seal to selectively placean internal gas chamber in fluid communication with an external volume,in other embodiments, any of the gas vent assemblies disclosed hereincan be operable to vent all or a portion of the pressurized gas to asecond region within the housing. Further, any of the gas ventassemblies disclosed herein can include any suitable valve arrangement.For example, in some embodiments a gas vent assembly and/or a portion ahousing can include a tear-through seal that is punctured or torn when aportion of a medicament carrier or a portion of an elastomeric membermoves past a specific point during a delivery event. In otherembodiments, a gas vent assembly and/or a portion a housing can includea movable valve member (e.g., a poppet, ball, or the like) that is movedto release pressure when a portion of a medicament carrier or a portionof an elastomeric member moves past a specific point during a deliveryevent.

Although the housings are described herein as having a rectangular orcylindrical shape, in other embodiments, any of the housings describedherein can have any suitable shape. For example, any of the housingsdescribed herein can have a substantially oval shape. Moreover, any ofthe housings described herein can be made of any suitable material, suchas polymers, metallic materials, or the like. Moreover, in someembodiments, the gas chamber portion of the housing can be constructedfrom a metallic material to withstand the pressure exerted therein. Forexample, in some embodiments a portion of a medicament cavity or gaschamber can include a steel sleeve.

Although the medical injector 4000 and the medical injector 8000 areshown and described as being actuated from the distal end via the base4510 and the base 8510, respectively, in other embodiments, any of themedicament delivery devices can be actuated in any suitable manner. Forexample, in some embodiments, any of the medical injectors describedherein can include an actuator on a side portion of the housing that isdepressed or moved inward relative to the housing to actuate the energystorage member. Such embodiments can be similar to the side actuationmechanisms (e.g., the mechanism 7450) shown and described in U.S. Pat.No. 7,648,482, entitled “Devices, Systems, and Methods for MedicamentDelivery,” the entire disclosure of which is incorporated herein byreference in its entirety. In other embodiments, any of the medicalinjectors described herein can include an actuator on a proximal of thehousing that is depressed or moved inward relative to the housing toactuate the energy storage member.

In some embodiments, any of the medical injectors described herein caninclude a sensor-based actuator that is not moved relative to thehousing to actuate the energy storage member. In such embodiments, theactuator can include a sensor that detects being disposed at anappropriate target location, and that produces a signal that is used toactuate the energy storage member.

Although the safety lock 4700 and the safety lock 8700 are shown anddescribed as being removed from their respective housings in a distaldirection, in other embodiments, any of the safety locks shown anddescribed herein can be moved in any suitable manner to “arm” the devicefor use. For example, in some embodiments, a medicament delivery devicecan include a safety lock that remains attached to the housing (i.e.,that is not removed during use). In other embodiments, the “arming”procedure can include multiple steps: first, the needle sheath can beremoved, and second, a safety lock can be moved in any direction. Forexample, in some embodiments, any of the safety locks described hereincan be a “side pull” safety lock, such as those shown and described inU.S. Pat. No. 7,648,482, entitled “Devices, Systems, and Methods forMedicament Delivery,” the entire disclosure of which is incorporatedherein by reference in its entirety. In other embodiments, any of thesafety locks described herein can be twisted or rotated relative to thehousing to enable the actuator to be moved.

In some embodiments, a safety lock initiate the removal of a needlesheath assembly without being a distal-pull safety lock. For example, insome embodiments, any of the safety locks described herein can be a“side pull” or proximally located safety lock that interacts with aneedle sheath (or sheath assembly). Upon movement relative to thehousing, the needle sheath (or sheath assembly) can be released from themedicament container assembly, and can fall from the device, therebyexposing the needle for use.

In some embodiments, the electronic circuit system of the typesdescribed herein can be used in either an actual medicament deliverydevice or a simulated medicament delivery device. A simulated medicamentdelivery device can, for example, correspond to an actual medicamentdelivery device and can, for example, facilitate training a user in theoperation of the corresponding actual medicament delivery device.

The simulated medicament delivery device can simulate the actualmedicament delivery device in any number of ways. For example, in someembodiments, the simulated medicament delivery device can have a shapecorresponding to a shape of the actual medicament delivery device, asize corresponding to a size of the actual medicament delivery deviceand/or a weight corresponding to a weight of the actual medicamentdelivery device. Moreover, in some embodiments, the simulated medicamentdelivery device can include components that correspond to the componentsof the actual medicament delivery device. In this manner, the simulatedmedicament delivery device can simulate the look, feel and sounds of theactual medicament delivery device. For example, in some embodiments, thesimulated medicament delivery device can include external components(e.g., a housing, a needle guard, a sterile cover, a safety lock or thelike) that correspond to external components of the actual medicamentdelivery device. In some embodiments, the simulated medicament deliverydevice can include internal components (e.g., an actuation mechanism, acompressed gas source, a medicament container or the like) thatcorrespond to internal components of the actual medicament deliverydevice.

In some embodiments, however, the simulated medicament delivery devicecan be devoid of a medicament and/or those components that cause themedicament to be delivered (e.g., a needle, a nozzle or the like). Inthis manner, the simulated medicament delivery device can be used totrain a user in the use of the actual medicament delivery device withoutexposing the user to a needle and/or a medicament. Moreover, thesimulated medicament delivery device can have features to identify it asa training device to prevent a user from mistakenly believing that thesimulated medicament delivery device can be used to deliver amedicament. For example, in some embodiments, the simulated medicamentdelivery device can be of a different color than a corresponding actualmedicament delivery device. Similarly, in some embodiments, thesimulated medicament delivery device can include a label clearlyidentifying it as a training device.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments where appropriate. For example, any of the devices shownand described herein can include an electronic circuit system asdescribed herein.

What is claimed is:
 1. An apparatus, comprising: a housing having ahousing length along a longitudinal axis; an energy storage memberdisposed within the housing, the energy storage member configured toproduce a force when the energy storage member is actuated; a medicamentcontainer disposed within the housing, the medicament container havingan elastomeric member disposed therein, the medicament container coupledto a needle, the medicament container having a container length; acarrier coupled to the medicament container, the carrier configured tomove from a first carrier position to a second carrier position inresponse to the force produced by the energy storage member such thatthe needle moves from a first needle position, in which the needle isdisposed within the housing, to a second needle position, in which aportion of the needle extends from the housing, wherein the elastomericmember configured to move within the medicament container from a firstposition to a second position to convey a medicament from the medicamentcontainer when the carrier is in the second carrier position; and aratio of the housing length to the container length being less thanabout 1.5.
 2. The apparatus of claim 1, wherein: the carrier moves fromthe first carrier position to the second carrier position by a carrierdistance; the elastomeric member is configured to move a stroke distancewithin medicament container to convey the medicament; and a ratio of thehousing length to a sum of the container length, the carrier traveldistance, and the stroke distance is less than about
 1. 3. The apparatusof claim 1, wherein: the housing includes a first stop surface and asecond stop surface, the first stop surface configured to limit proximalmovement of the carrier when the carrier is in the first carrierposition, the second stop surface configured to limit distal movement ofthe carrier when the carrier is in the second carrier position.
 4. Theapparatus of claim 1, wherein: the housing defines a gas chamber; theenergy storage member is configured to produce a pressurized gas withinthe gas chamber; a proximal surface of the elastomeric member defines afirst portion of a boundary of the gas chamber; and a proximal surfaceof the carrier defines a second portion of the boundary of the gaschamber.
 5. The apparatus of claim 4, wherein: an outer surface of thecarrier includes a seal in sliding contact with an inner surface of thehousing, the seal fluidically isolating the gas chamber from an exteriorvolume.
 6. The apparatus of claim 4, wherein a side wall of the housingdefines an opening configured to selectively place the gas chamber influid communication with an exterior volume, the apparatus furthercomprising: a gas vent assembly having a first member and a secondmember, the first member coupled to the elastomeric member, the secondmember coupled within the opening, the first member of the gas ventassembly configured to move with the elastomeric member such that thesecond member moves relative to the opening to fluidically couple thegas chamber with the exterior volume when the elastomeric member is inthe second position.
 7. The apparatus of claim 6, wherein: the gas ventassembly is configured to transition from a collapsed configuration toan expanded configuration when the elastomeric member moves within themedicament container.
 8. The apparatus of claim 7, wherein: the secondmember includes a valve portion, the valve portion is configured to moverelative to the opening when the gas vent assembly transitions from thecollapsed configuration to the expanded configuration to place the gaschamber in fluid communication with the exterior volume.
 9. Theapparatus of claim 8, wherein: the valve portion of the second memberdefines a gas release path, the valve portion disposed within theopening of the housing such that the gas release path is fluidicallyisolated from the gas chamber via a seal member when the gas ventassembly is in the collapsed configuration.
 10. The apparatus of claim7, wherein: the gas vent assembly has a first length when in thecollapsed configuration and a second length when in the expandedconfiguration; and a ratio of the second length to the first length isgreater than about 2.0.
 11. The apparatus of claim 7, wherein: theelastomeric member is configured to move a stroke distance within themedicament container in response to the pressurized gas being within thegas chamber; and the gas vent assembly has a first length when in thecollapsed configuration, a ratio of the first length to the strokedistance being less than about 1.2.
 12. The apparatus of claim 7,wherein: a length of the gas vent assembly when in the expandedconfiguration is configured to set a dosage amount.
 13. An apparatus,comprising: a housing having a housing length along a longitudinal axis;an energy storage member disposed within the housing, the energy storagemember configured to produce a force when the energy storage member isactuated; a medicament container disposed within the housing, themedicament container having an elastomeric member disposed therein, themedicament container coupled to a needle, the medicament containerhaving a container length; a carrier coupled to the medicamentcontainer, the carrier configured to move from a first carrier positionto a second carrier position by a carrier distance in response to theforce produced by the energy storage member such that the needle movesfrom a first needle position, in which the needle is disposed within thehousing, to a second needle position, in which a portion of the needleextends from the housing, wherein the elastomeric member configured tomove within the medicament container through a stroke distance to conveya medicament from the medicament container when the carrier is in thesecond carrier position; and a ratio of the housing length to a sum ofthe container length, the carrier distance, and the stroke distance isless than about
 1. 14. The apparatus of claim 13, further comprising: arelease mechanism configured to release the force from the elastomericmember after the elastomeric member has been moved within the containerbody through the stroke distance.
 15. An apparatus, comprising: ahousing defining a gas chamber, the housing having a housing lengthalong a longitudinal axis; an energy storage member disposed within thehousing, the energy storage member configured to produce a pressurizedgas within the gas chamber; a first medicament container assemblydisposed within the housing, the first medicament container assemblyincluding a first container body and a first elastomeric member disposedwithin the first container body, the first medicament container assemblyincluding a first needle coupled to a distal end portion of the firstcontainer body, the first medicament container assembly configured tomove within the housing in response to a force exerted by thepressurized gas such that the first needle moves from within the housingto an exterior volume outside of the housing, the first elastomericmember configured to move within the first container body to convey afirst medicament contained therein in response to the force, the firstmedicament container assembly having a container length; a secondmedicament container assembly disposed within the housing, the secondmedicament container assembly including a second container body and asecond elastomeric member disposed within the second container body, thesecond medicament container assembly including a second needle coupledto a distal end portion of the second container body, the secondmedicament container assembly configured to move within the housing inresponse to the force such that the second needle moves from within thehousing to the exterior volume, the second elastomeric member configuredto move within the second container body to convey a second medicamentcontained therein in response to the force; and a ratio of the housinglength to the container length being less than about 1.5.
 16. Theapparatus of claim 15, wherein: the first medicament container assemblyis non-coaxial with the second medicament container assembly.
 17. Theapparatus of claim 15, further comprising: a carrier coupled to thefirst medicament container assembly, the carrier configured to move froma first carrier position to a second carrier position in response to theforce produced by the energy storage member, wherein: the firstelastomeric member is configured to move within the first medicamentcontainer assembly from a first position to a second position when thecarrier is in the second carrier position, the carrier moves from thefirst carrier position to the second carrier position by a carrierdistance, the first elastomeric member is configured to move a strokedistance within the first medicament container to convey the firstmedicament, and a ratio of the housing length to a sum of the containerlength, the carrier distance, and the stroke distance is less than about1.
 18. The apparatus of claim 15, further comprising: a releasemechanism configured to release at least a portion of the force from thefirst elastomeric member and the second elastomeric member after thefirst elastomeric member has been moved within the first container bodya predetermined distance and the second elastomeric member has beenmoved within the second container body the predetermined distance. 19.The apparatus of claim 18, wherein: a side wall of the housing definingan opening configured to selectively place the gas chamber in fluidcommunication with the exterior volume; and the release mechanism has afirst member, a second member, and a third member, the first membercoupled to and configured to move with the first elastomeric member, thesecond member coupled to and configured to move with the secondelastomeric member, the third member coupled to the first member and thesecond member, the third member configured to move relative to theopening to fluidically couple the gas chamber with the exterior volumewhen each of the first elastomeric member and the second elastomericmember move the predetermined distance.
 20. The apparatus of claim 15,wherein the energy storage member is disposed between the firstmedicament container assembly and the second medicament containerassembly within the housing.